FDA Adverse Event
Malfunction
Summary report: N
TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH
MDR report key: 1193116
·
Received October 6, 2008
Report
- Report Number
- 9617544-2008-00102
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 28, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HXC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, WILL BE MADE AVAILABLE IN A SUPPLEMENTAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE SCREW, THE HEX BROKE IN 3 PIECES. TWO FLEW ACROSS THE ROOM. ALL PIECES WERE ACCOUNTED FOR, AND A SPARE DRIVER WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH | INSTRUMENT | HXC | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |