Device product
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Z-0669-2018
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 79021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 567 units
- Official record key
device-enforcement:Z-0669-2018
Official wording
Reason: May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Code information: Lot numbers FT00227 9972971 H028400 H161606 H288454
Distribution pattern: Distribution to US, Canada, and Germany.
Derived failure modes
-
Unknown
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.