PERIOST-ELEV SLIGHTLY CURV-BLADE ROUND E
Received Mar 26, 2013 · Event occurred Feb 25, 2013
Report 8030965-2013-01144 · MDR key 3021376
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, THE PERIOSTEAL EVELVATOR BROKE IN THE OR. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.
Description of Event or Problem
THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).
Additional Manufacturer Narrative
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR NOT AVAILABLE AS DEVICE IS OLDER THAN 10 YEARS. ACCORDING TO (B)(4) THE DOCUMENTS FOR INSTRUMENTS HAVE TO BE STORED FOR 10 YEARS. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE FRACTURE SURFACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS RELATED TO A MECHANICAL OVERLOADING DURING USE. THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS.
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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.