BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 3041692 · Received April 8, 2013

    Report

    Report Number
    3003787298-2013-10069
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT ONE SIDE OF THE TIP IS BROKEN OFF AS NOTED. THERE ARE NUMEROUS DEEP GOUGES AND NICKS ALL OVER THE TOP AND SIDE OF THE REMAINING TIP. BASED ON THE LOCATION OF THE DAMAGE TO THE REMAINING TIP, IT IS OBVIOUS THAT THE IMPACTOR TIP WAS NOT ALWAYS FULLY SEATED AGAINST THE PLATE BEFORE BEING USED. ALSO, THE DEPTH OF THE GOUGES AND DEFORMATION AROUND THEM INDICATE THAT THE IMPACTOR WAS STRUCK QUITE HARD AT TIMES INSTEAD OF BEING USED TO GENTLY SEAT THE PLATE AS REQUIRED BY THE TECHNIQUE GUIDE. THE THREADED TIP ON THE OTHER END IS INTACT AND IN GOOD CONDITION. THE RETURNED DEVICE WAS MANUFACTURED IN SEPTEMBER 2000 AND IS OVER 11 YEARS OLD. THE DAMAGE ON THE REMAINING TIP INDICATES THAT THE TIP WAS NOT ALWAYS PROPERLY SEATED ON THE PLATE WHEN THE IMPACTOR WAS STRUCK AND THAT THE STRIKES WERE CONSIDERABLY MORE THAN RECOMMENDED BY THE TECHNIQUE GUIDE. BASED ON THE AGE AND DAMAGE SEEN ON THE DEVICE, THERE ARE NO INDICATIONS OF DESIGN OR MANUFACTURING RELATED ISSUES AND THEREFORE IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID. 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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DHS HIP PROCEDURE THE SURGEON NOTED THE CONNECTING SCREW IS BREAKING AT THE THREADS AND THE FLATS ON THE GUIDE SHAFT ARE BENT. DURING THE IMPACTION PROCESS, TWO IMPACTOR TIPS BROKE. THE SURGEON WAS ABLE TO COMPLETE WITH PROCEDURE WITH THE SECOND TIP WITH NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144051 TIP FOR DHS®/DCS® IMPACTOR (338.28) HWA SYNTHES JENNERSVILLE 4152301

    Patients

    Seq Age Sex Outcome Treatment
    1