TRIDENT ACET WINDOW TRIAL 58MM
Report
- Report Number
- 0002249697-2014-04109
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 8, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
AN EVENT REGARDING THREAD DAMAGE INVOLVING A TRIDENT WINDOW WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CONFIRMS THE REPORTED THREAD DAMAGE. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN SIMILAR PREVIOUS REPORTED EVENTS. CONCLUSIONS: THE EVENT IS RELATED TO COMPLAINTS INVESTIGATED UNDER A CAPA. THE CAPA IDENTIFIED THE POTENTIAL FOR CROSS-THREADING OF THE TRIAL AND MATING CUTTING EDGE IMPACTOR/POSITIONER DURING ASSEMBLY WHICH COULD CONTRIBUTE TO THREAD DAMAGE OVER TIME. AS A RESULT, THIS DEVICE WAS MADE OBSOLETE AND A NEW DESIGN WITH DIFFERENT MATERIAL WAS LAUNCHED.
TRIAL LINER WOULD NOT SOLIDLY ENGAGE WITH THE CUP/TRIAL IMPACTOR EXTRACTOR.
TRIAL LINER WOULD NOT SOLIDLY ENGAGE WITH THE CUP/TRIAL IMPACTOR EXTRACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701188 | TRIDENT ACET WINDOW TRIAL 58MM | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS-MAHWAH | 92261001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |