BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE REDUCTION FORCEPS-LARGE

    MDR report key: 3072672 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10917
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    September 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. ADDITIONAL PRODUCT DEVELOPMENT EVALUATIONS STATED THAT THERE ARE NO PRIOR COMPLAINTS FOR THIS INSTRUMENT IN THE 2 YEAR HISTORY AND THE COMPLAINT CONDITION PRESENTS MINIMAL RISK. THE SUBJECT LOT WAS MANUFACTURED IN MAY 2003 SO THE DEVICE IS OVER 8 YEARS OLD AND BASED ON THE CONDITION OF THE DEVICE, IT HAS SEEN EXTENSIVE USE. THAT COUPLED WITH THE AGE AND USE HISTORY (DEVICE IS FROM AN EVALUATION SET) SUPPORT THE CONCLUSION THAT THE DESIGN IS ACCEPTABLE AND THERE ARE NO MANUFACTURING RELATED ISSUES. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    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 EVENT EVALUATION REVEALS, THE DESIGN IS ACCEPTABLE. THE PART WAS RECEIVED, NO EVALUATION IS AVAILABLE. THERE ARE NO INDICATIONS OF EITHER MANUFACTURING OR DESIGN RELATED ISSUES WITH THE DEVICE. THE FRACTURE SURFACE IS UNIFORM AND CONSISTENT WITH AN OVER STRESS SITUATION. THE SPECIFIC CONDITIONS OF THE CASE IN WHICH THIS INSTRUMENT BROKE ARE UNKNOWN BUT THE FAILURE IS CONSISTENT WITH THE DEVICE BEING SUBJECTED TO EXTREMELY HIGH LOAD WHICH CAUSED THE TIP TO BREAK. THIS COMPLAINT IS DEEMED INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBLE FRACTURE PROCEDURE, THE TIP OF THE REDUCTION FORCEPS BROKE OFF WHEN THE SURGEON ATTEMPTED TO REDUCE THE FRACTURE. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT. THE SURGEON USED ANOTHER REDUCTION FORCEPS TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175035 BONE REDUCTION FORCEPS-LARGE HTD SYNTHES GMBH A7 MA 20

    Patients

    Seq Age Sex Outcome Treatment
    1