PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE
Received Apr 14, 2013 · Event occurred Jun 23, 2011
Report 8030965-2013-10876 · MDR key 3057075
Device
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE TRYING TO REDUCE A FRACTURE FRAGMENT FOR AN OPEN REDUCTION INTERNAL FIXATION OF A PROXIMAL HUMERUS, THE HANDLE OF THE PERIOSTEAL ELEVATOR BROKE. ALL BROKEN PIECES WERE RETRIEVED AND CONFIRMED BY X-RAY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR FILE (B)(4).
Additional Manufacturer Narrative
ADDITIONAL NARRATIVE: 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 WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND UPON EXAMINATION, THE HANDLE WAS FOUND TO BE BROKEN AS NOTED IN THE COMPLAINT. THE PORTION OF THE HANDLE ATTACHED TO THE INSTRUMENT SHAFT WAS BROKEN CLEANLY AND WAS PERPENDICULAR TO THE AXIS OF THE SHAFT. THE BREAK ON THE LOOSE HANDLE PIECE WAS SIMILAR OVER HALF THE WIDTH OF THE PART AND HAD AN OBLIQUE BREAK FOR THE REMAINING THICKNESS. THE OBLIQUE AREA CORRESPONDED TO THE LENGTH OF THE EXPOSED SHAFT THAT HAD BEEN ENCAPSULATED IN THE HANDLE. THERE WAS A SMALL PIECE FROM THE OBLIQUE BREAK THAT WAS NOT RETURNED. THE BREAK IS CONSISTENT WITH THE DEVICE BEING USED AS A LEVER TO AID IN FRACTURE REDUCTION AS DESCRIBED IN THE COMPLAINT. SINCE THE PERIOSTEAL ELEVATOR IS NOT INTENDED FOR USE IN THIS MANNER, IT IS BELIEVED THAT THIS LED DIRECTLY TO THE COMPLAINT CONDITION AND IT IS THEREFORE INVALID FROM BOTH MANUFACTURING AND DESIGN STANDPOINTS. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE.
Additional Manufacturer Narrative
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.