FDA Adverse Event
Malfunction
Summary report: N
PIN DRIVER
MDR report key: 5328771
·
Received December 28, 2015
Report
- Report Number
- 0008031020-2015-00657
- Event Type
- Malfunction
- Date Received
- December 28, 2015
- Date of Event
- April 23, 2013
- Report Date
- April 26, 2013
- Manufacturer
- STRYKER GMBH
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WITH GUIDANCE FROM THE POLICY BRANCH OF THE FDA, REPORTED BY STRYKER GMBH,(B)(6) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6), HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. 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
BROKEN PRONG (DISTAL END) ON PIN DRIVER ASSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853674 | PIN DRIVER | PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME | NTG | STRYKER GMBH | 901-0025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |