FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FRS SCREW
MDR report key: 1569321
·
Received December 30, 2009
Report
- Report Number
- 1818910-2009-07509
- Event Type
- Injury
- Date Received
- December 30, 2009
- Date of Event
- December 1, 2009
- Report Date
- December 1, 2009
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HWC
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE SCREW HEAD STRIPPED, COULD NOT ADVANCE THE SCREW FURTHER OR REMOVE. THE SURGEON CUT THE REMAINING SCREW OFF TO BONE LEVEL. THIS ISSUE CAUSED A 45 MINUTE DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY FRS SCREW | TRAUMA DEVICE | HWC | DEPUY ACE S.A. 'R.L. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |