FDA Adverse Event
Injury
Summary report: N
ONE-STEP INSERTION WRENCH OMEGA
MDR report key: 2850948
·
Received November 20, 2012
Report
- Report Number
- 8031020-2012-00279
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HXC
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: (B)(4) STANDARD LAG SCREW, OMEGA 95 MM LENGTH, LOT # Z19787; (B)(4) ELASTOSIL T-HANDLE LARGE, AO COUPLING, LOT #X05397; (B)(4) CONNECTING BOLT, OMEGA (B)(4).
Description of Event or Problem · 1
THE SURGEON, REPORTED VIA THE SALES REP, WHO WAS PRESENT DURING THE PROCEDURE, THAT THE LAG SCREW INSERTER ON THE ONE STEP INSERTION TECHNIQUE FAILED. THE SURGEON REPORTED THAT THE LAG SCREW INSERTER DISENGAGED FROM THE THREAD AND SPREAD THE BASE OF THE LAG SCREW RENDERING THE PLATE UNABLE TO BE LOCATED OVER THE LAG SCREW. THE SURGEON ADDED THAT ANOTHER LAG SCREW WAS REQUIRED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE-STEP INSERTION WRENCH OMEGA | INSTRUMENT | HXC | STRYKER OSTEOSYNTHESIS SELZACH | NA | U16544 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |