FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER SHAFT
MDR report key: 1014015
·
Received March 13, 2008
Report
- Report Number
- 2249697-2008-00063
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 14, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HXX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE TIP OF THE UNIVERSAL DRIVER BROKE WHEN THE SURGEON WAS TIGHTENING A SCREW UP IN THE ACETABULAR. A FRAGMENT OF THE DRIVER REMAINED IN THE HEAD OF THE SCREW. THE SURGEON WAS UNABLE TO REMOVE IT FROM THE HEAD OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER SHAFT | INSTRUMENT | HXX | STRYKER ORTHOPAEDICS MAHWAH | NA | FZK372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |