BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET FLEX CLAMP BROACH HNDL E

    MDR report key: 9368418 · Received November 25, 2019

    Report

    Report Number
    0001825034-2019-05255
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    February 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF TWO OFFSET FLEX CLAMP BROACH HNDL E WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE STRIKE PLATE HAD FRACTURED ON BOTH HANDLES WITH ONLY ONE STRIKE PLATE WAS RETURNED WITH BOTH HANDLES. BOTH HANDLES SHOW IMPACT MARKS ON THE BODY OF THE HANDLE. THE SINGLE RETURNED STRIKE PLATE SHOWS IMPACT MARKS BOTH ON THE TOP AND THE UNDERSIDE AROUND THE FRACTURE SITE. THE FEATURES OF THESE FRACTURE SURFACES AND MODE ALIGN WITH THOSE REPORTED IN SUMMARY OF FAILURE ANALYSIS OF WELDED STRIKE. PLATES ON BROACH HANDLES. THE FEATURES OF THIS FRACTURE SURFACE AND MODE ALIGN WITH THOSE REPORTED IN SUMMARY OF FAILURE ANALYSIS OF WELDED STRIKE PLATES ON BROACH HANDLES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OFFSET FLEX CLAMP BROACH HNDL E, PN 31-555408, LN 577290. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05256. CUSTOMER HAS INDICATED THAT THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE HANDLE OF THE RASP DISASSOCIATED FROM THE STRIKEPLATE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167471 OFFSET FLEX CLAMP BROACH HNDL E ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 402880

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE