FDA Adverse Event
Malfunction
Summary report: N
12.6CM TAPERED ATTACH, BM
MDR report key: 3811826
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-04958
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- July 6, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GFF
- PMA / PMN Number
- K974025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM USA STATING THAT THE DEVICE HAS DAMAGED BEARINGS. IT IS UNKNOWN IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523781 | 12.6CM TAPERED ATTACH, BM | GFF | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |