FDA Adverse Event
Malfunction
Summary report: N
1/8" PEG DRILL
MDR report key: 3213692
·
Received July 9, 2013
Report
- Report Number
- 0002249697-2013-02230
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 11, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K123486
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT FRACTURED WAS LIKELY CAUSED BY A BENDING FORCE DURING USE. INSPECTION OF THE RETURNED DEVICE INDICATES NO MATERIAL OR MANUFACTURING DEFECTS HAVE BEEN IDENTIFIED.
Description of Event or Problem · 1
STEP DRILL BROKE DURING PROCEDURE AND USE.
Description of Event or Problem · 1
STEP DRILL BROKE DURING PROCEDURE AND USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312373 | 1/8" PEG DRILL | INSTRUMENT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | SC2T07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |