PERIOST-ELEV SLIGHTLY CURV-BLADE ROUND E
Received Apr 10, 2013
Report 8030965-2013-01518 · MDR key 3049465
Device
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: THE CURVE BROKE OFF. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT AT THIS TIME. THIS IS 1 OF 1 REPORT FOR THIS EVENT FOR COMPLAINT NUMBER (B)(4).
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Additional Manufacturer Narrative
ADDITIONAL NARRATIVE:DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.THE INVESTIGATION HAS SHOWN THAT THE PERIOSTEAL ELEVATOR IS BROKEN OFF AT THE BLADE. THE DAMAGE TO THE BLADE ITSELF CONFIRMED US THAT THIS INSTRUMENT WAS USED OFTEN. THEREFORE WE ASSUME THAT THE FRACTURE WAS CAUSED BY THE CONSTANT MECHANICAL STRESS DURING USE. FURTHER INVESTIGATION OF MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN CONFORMITY WITH THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.(B)(4): PLACEHOLDER.