PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE
Received Nov 30, 2015
Report 2520274-2015-17515 · MDR key 5254240
Device
Product problems
- Break
- Material Fragmentation
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: DURING STERILE PROCESSING A PERIOSTEAL ELEVATOR HANDLE BROKE; THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THE RETURNED INSTRUMENT (399.48 LOT UNKNOWN) WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DEVICE HANDLE WAS BROKEN AND A DISTAL PORTION WAS FOUND TO BE MISSING AND NOT RETURNED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH WEAR/TEAR OF THE INSTRUMENT¿S PHENOLIC HANDLE WHICH IS SUSCEPTIBLE TO BECOMING BRITTLE AFTER BEING SUBJECTED TO YEARS OF THERMAL CYCLING WHICH ROUTINELY OCCURS DURING STERILIZATION. THIS INVESTIGATION SUMMARY IS APPROVED. 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.
Additional Manufacturer Narrative
DATE ON FOLLOW-UP WAS REPORTED AS OCT. 1, 2015, BUT SUPPOSE TO BE DEC 1, 2015. 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.
Additional Manufacturer Narrative
(B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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
IT WAS REPORTED A PIECE OF A HANDLE BROKE OFF A PERIOSTEAL ELEVATOR DURING DECONTAMINATION AND WASHING OF THE DEVICE. THE DEVICE IS AVAILABLE FOR RETURN BUT, THE BROKEN PIECE WAS DISCARDED AND NOT AVAILABLE FOR RETURN. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).