FDA Adverse Event
Malfunction
Summary report: N
TWIST DRILL FOR 6MM SCREWS, DIAM.1.0X50MM, WL 7MM
MDR report key: 2171448
·
Received June 30, 2011
Report
- Report Number
- 8010177-2011-00188
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HBE
- PMA / PMN Number
- K070876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
TWO TWIST DRILLS DISASSEMBLED DURING THE SAME CASE. NO REMNANTS WERE LEFT IN THE PATIENT, BUT SOME OF THE PIECES WERE DISCARDED BEFORE REP COULD RETRIEVE. CASE ENDED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWIST DRILL FOR 6MM SCREWS, DIAM.1.0X50MM, WL 7MM | IMPLANT | HBE | STRYKER OSTEOSYNTHESIS FREIBURG | NA | Y10-10/2008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |