FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER SHAFT
MDR report key: 1880074
·
Received October 5, 2010
Report
- Report Number
- 2249697-2010-01322
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- September 9, 2010
- Report Date
- September 13, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. MANUFACTURE DATE: 05/02/07 FOR LOT # F2H3379.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHILE IMPLANTING THE GAP SCREW INTO THE TRITANIUM REVISION CUP, WAS USING THE SCREWDRIVER, AND THE TIP "WELDED ITSELF" ONTO THE SCREW. WHEN DR TRIED TO FORCE IT, THE TIP BROKE OFF INSIDE THE HEAD. REMOVED THE TIP AND TRIED ANOTHER SCREWDRIVER AND THE TIP OF THE OTHER IS ABOUT TO BREAK OFF, IT IS TWISTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER SHAFT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | F4T8678 / F2H3379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |