BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 3062353 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10869
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE PART WAS RECEIVED WITH ONE OF THE SERRATED JAWS BROKEN OFF. THE FRACTURE SURFACE IS HOMOGENOUS INDICATING MATERIAL UNIFORMITY. BROWN RESIDUE IS NOTED ALL OVER THE DEVICE, PARTICULARLY IN THE RECESSES IN THE ACTUATION POINT BETWEEN THE JAWS, THE UNDERSIDE OF THE HANDLES AND IN THE LOCKING MECHANISM. THIS SHOWS EVIDENCE OF EXTENSIVE USAGE. DESIGN RELATED ISSUES WERE NOT FOUND. THE COMPLAINT CONDITION IS DUE TO WEAR AND TEAR AND THERE IS NO INDICATION OF DESIGN OR MANUFACTURING RELATED ISSUES WITH THIS DEVICE. THIS COMPLAINT IS CONSIDERED INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SERRATED PART OF THE REDUCTION FORCEPS BROKE. ALL PIECES WERE RETRIEVED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163466 REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET HTD SYNTHES GMBH 5004199

    Patients

    Seq Age Sex Outcome Treatment
    1