BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCT FORCEPS POINTS NARROW

    MDR report key: 6462377 · Received April 5, 2017

    Report

    Report Number
    0001825034-2017-02428
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 2, 2017
    Report Date
    June 30, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HYA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    (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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244356 REDUCT FORCEPS POINTS NARROW SURGICAL INSTRUMENT, MANUAL HYA BIOMET TRAUMA N/A 0316GH

    Patients

    Seq Age Sex Outcome Treatment
    1