PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE
Received Oct 26, 2017 · Event occurred Oct 2, 2017
Report 3009417901-2017-10022 · MDR key 6982173
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL TELEPHONE NOT AVAILABLE FOR REPORTING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 31.MAR.2008. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR BROKE. IT IS NOT KNOWN HOW THE ISSUE OCCURRED. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE THIS IS REPORT 1 OF 1 FOR (B)(4).