FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM TORQUE WRENCH
MDR report key: 3040191
·
Received April 8, 2013
Report
- Report Number
- 0009617544-2013-00125
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 11, 2013
- Manufacturer
- STRYKER SPINE-FRANCE
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Additional Manufacturer Narrative · 1
AT RECEPTION OF THE INVOLVED XIA 3 TORQUE WRENCH, THE REPORTED EVENT WAS CONFIRMED. BASED ON EXTENDED INVESTIGATION CONDUCTED ON THIS ISSUE A NON-CONFORMANCE REPORT WAS INITIATED.
Description of Event or Problem · 1
XIA 3 TORQUE WRENCH TIP BROKE OFF DURING FINAL TIGHTENING INSIDE THE PATIENT. THERE WAS NO DELAY IN SURGERY AND THE BROKEN TIP WAS REMOVED FROM THE PATIENT.
Description of Event or Problem · 1
XIA 3 TORQUE WRENCH TIP BROKE OFF DURING FINAL TIGHTENING INSIDE THE PATIENT. THERE WAS NO DELAY IN SURGERY AND THE BROKEN TIP WAS REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143366 | XIA 3 TITANIUM TORQUE WRENCH | INSTRUMENT | LXH | STRYKER SPINE-FRANCE | 11E042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |