DEAN SCISSORS SERRATED 17 CM 6-
Received Oct 24, 2016
Report 0001032347-2016-00605 · MDR key 6051832
Device
Generic name
Scissors
Manufacturer
Biomet MicrofixationModel number
N/ACatalog number
51-0990
Lot number
120908L08
Product problems
- Device Inoperable
- Device Inoperable
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS REPORT ONE OF FOUR FOR THE SAME EVENT. REPORTS TWO THROUGH FOUR ARE REPORTED ON MFR #0001032347-2016-00606 THROUGH 0001032347-2016-00608.
Additional Manufacturer Narrative
IT IS NOTED THAT THE CUSTOMER SHOWS A POSSIBLE LOT OF 051815E15 FOR THIS ITEM. HOWEVER, THE LOT NUMBER COULD NOT BE CONFIRMED AT THIS TIME. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT ONE OF FOUR FOR THE SAME EVENT. REPORTS TWO THROUGH FOUR ARE REPORTED ON MFR #0001032347-2016-00606 THROUGH 0001032347-2016-00608.
Description of Event or Problem
IT IS REPORTED THAT THIS INSTRUMENT FELL APART DURING A PROCEDURE. IT IS REPORTED THAT ALL PARTS WERE RETRIEVED AND THERE WAS NO FOREIGN BODY IN THE PATIENT. IT IS REPORTED THAT THE EVENT DID NOT LEAD TO A DELAY OF MORE THAN THIRTY MINUTES.
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED AND THE LOT WAS IDENTIFIED IN THE EVALUATION. A VISUAL INSPECTION REVEALED MODERATE SIGNS OF WEAR INCLUDING MINOR SCRATCHES AND SPOTS OF DISCOLORATION. THIS PRODUCT WAS FOUND TO HAVE COME COMPLETELY DISASSEMBLED AFTER THE BLADE FRACTURED AT THE PIN; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE APPLIED FORCE. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT ONE OF NINE FOR THE SAME EVENT. REPORTS TWO THROUGH FOUR, AND FIVE THROUGH NINE ARE REPORTED ON MFR #0001032347-2016-00606-2 THROUGH 0001032347-2016-00608-2 AND 0001032347-2016-00770 THROUGH 0001032347-2016-00774.