CLICKX LOCKCAP T25 TAN
Report
- Report Number
- 8030965-2013-04161
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- July 20, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE MEASURABLE DIMENSIONS OF THE SENT LOCKING CAP WERE REVIEWED. IT WAS DETERMINED THAT THE DIMENSIONS ARE CONSISTENT WITH THE DIAGRAMS AND SPECIFICATIONS. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED THROUGH THE VISUAL AND MANUFACTURING DATA INVESTIGATION. AN ERROR IN MATERIAL OR ASSEMBLY CAN BE EXCLUDED. THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.
SADDLE LOOSENED FROM LOCKING CAP. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291942 | CLICKX LOCKCAP T25 TAN | HWC | SYNTHES GMBH | 7923671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |