FDA Adverse Event
Malfunction
Summary report: N
2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM
MDR report key: 1960339
·
Received December 16, 2010
Report
- Report Number
- 8010177-2010-00469
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 20, 2010
- Report Date
- November 23, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON INVESTIGATION THE FAILURE OF THE BLADE (FRACTURED TIP) WAS CAUSED BY THE ACTION OF TOO HIGH TORSIONAL AND BENDING FORCES. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THE INVESTIGATION.
Description of Event or Problem · 1
NURSE INFORMED SALES REP THAT TIP OF THE SCREWDRIVER GOT BROKEN DURING OPERATION. PART OF THE SCREWDRIVER TIP IS ATTACHED TO THE IMPLANTED SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS FREIBURG | NA | Z1-01/2009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |