Device product
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Z-1711-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 71277
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1495 US (37 OUS)
- Official record key
device-enforcement:Z-1711-2015
Official wording
Reason: affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Code information: Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040
Distribution pattern: Worldwide Distribution - US (nationwide) and Canada.
Derived failure modes
-
Unknown
affected parts and lots of the Cannulated Drill Bits have the potential to break during use