Device product
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
Z-0787-2016
Product summary
- Event
- Event 73076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 351
- Official record key
device-enforcement:Z-0787-2016
Official wording
Reason: Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
Code information: Cat. No. GTIN Lot Description 950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5 950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3 950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7 950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3 950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7 950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7
Distribution pattern: Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.
Derived failure modes
-
Unknown
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.