FDA Adverse Event
Other
Summary report: N
CANNULATED DRILL
MDR report key: 1941816
·
Received December 10, 2010
Report
- Report Number
- 8010177-2010-00463
- Event Type
- Other
- Date Received
- December 10, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- DZJ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
THE SURGEON REPORTS VIA OUR SALES REP THAT WHILE DRILLING OVER THE K-WIRE, THIS WIRE IS MILLED LEADING TO A BREAKAGE OF THE WIRE IN THE FRONT PART WHICH GOT STUCK IN THE BONE. THE SURGERY COULD BE FINISHED USING AN EXCHANGE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED DRILL | IMPLANT | DZJ | STRYKER OSTEOSYNTHESIS FREIBURG | NA | Z5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |