REDUCT FORCEPS POINTS NARROW
Received Apr 5, 2017 · Event occurred Mar 2, 2017
Report 0001825034-2017-02428 · MDR key 6462377
Device
Generic name
Surgical Instrument, Manual
Manufacturer
Biomet TraumaModel number
N/ACatalog number
939999444
Lot number
0316GH
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). QUANTITY: 2. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT IS REPORTED THAT THE TIP OF TWO FORCEPS FRACTURED DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02428, 04479. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL REVIEW OF THE TWO (2) DEVICES RETURNED IDENTIFIED THAT ONE PRONG ON EACH OF THE FORCEPS IS FRACTURED. MATERIAL ANALYSIS STATED THE FOLLOWING: "THE CLAMPS HAVE SCRAPES & SCRATCHES BUT APPEARED AS DESIGNED EXCEPT FOR NEARLY IDENTICAL FRACTURED TIPS. BOTH FRACTURES OCCURRED AT THE MOST DISTAL NOTCH NEARLY PERPENDICULAR TO THE TIP AXIS. FRACTURE ARTIFACTS SUGGEST A BENDING OVERLOAD FRACTURE MAY HAVE INITIATED. THE POSSIBLE DIRECTIONS OF THE FRACTURES SUGGEST THEY BROKE DURING CLAMPING. AN XRF SCAN CONFIRMED THE MATERIAL AS 410/420 STAINLESS STEEL. A FIELD PHOTO SHOWS THE CLAMPS IN THE OR WITH ONE OF THE FRACTURED TIPS, WHICH WAS NOT RETURNED." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.