FDA Adverse Event
Malfunction
Summary report: N
INSTRUMENT TRAY # 2 A3 NAIL
MDR report key: 5319942
·
Received December 22, 2015
Report
- Report Number
- 0008031020-2015-00612
- Event Type
- Malfunction
- Date Received
- December 22, 2015
- Date of Event
- November 5, 2013
- Report Date
- November 5, 2013
- Manufacturer
- STRYKER GMBH
- Product Code
- HSB
- PMA / PMN Number
- K112982
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.
Description of Event or Problem · 1
PARTICLES HAVE BEEN OBSERVED IN THE BASE OF THE TRAYS (BRACKET COATING); SEVERAL BRACKETS ARE BENT OR LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845701 | INSTRUMENT TRAY # 2 A3 NAIL | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |