BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 4147382 · Received October 7, 2014

    Report

    Report Number
    3003787298-2014-10046
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT #7137618 NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE CUSTOMER REPORTED THE TIP LOOKED LIKE IT WAS GOING TO BREAK OFF. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS CRACKED. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE RETURNED PART WAS RECEIVED WITH A BROKEN TIP. THE DHS®/DCS® IMPACTOR (338.28) IS ONE OF THE TRAUMA TOOLS INCLUDED IN THE LCP DYNAMIC HELICAL HIP SYSTEM (DHHS) AND THE DHS/DCS DYNAMIC HIP AND CONDYLAR SCREW SYSTEM. THE REPLACEMENT TIP FOR THE DHS®/DCS® IMPACTOR (338.26) IS USED TO REPLACE THE STANDARD TIP PROVIDED ON THE DHS®/DCS® IMPACTOR. DHS®/DCS® IMPACTORS ARE UTILIZED WHEN A PLATE IS HAVING DIFFICULTY SLIDING INTO A REAMED CAVITY, AND NOT COMPLETELY FLUSH AGAINST THE BONE. DRAWING 338_26 (REV F) (15OCT04) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. THE COMPLAINT WAS CONFIRMED WITH ALL THREE IMPACTOR TIPS (338.26). IT WAS CONFIRMED THAT THE IMPACTOR TIP FROM LOT 6043333 WAS DAMAGED AND PART OF THE TIP WAS BROKEN OFF, THE IMPACTOR TIP FROM LOT 7137618 HAD CUTS IN THE PLASTIC AREA WHICH IS USED TO IMPACT PLATES, THE IMPACTOR TIP FROM LOT 7253826 WAS BADLY DAMAGED AND A SIGNIFICANT PORTION OF THE TIP WAS BROKEN OFF. THE ROOT CAUSE OF THE DAMAGE SUSTAINED BY THE IMPACTOR TIPS WAS UNABLE TO BE ACCURATELY DETERMINED, BUT IT IS POSSIBLE THAT USING THE IMPACTORS IN A METHOD WHICH IS NOT INDICATED IN THE DHS/DCS AND LCP TECHNIQUE GUIDES COULD HAVE CONTRIBUTED TO THE DAMAGE. IF THE IMPACTOR WAS NOT PROPERLY SEATED AND THE SURGEON USED EXCESSIVE FORCE DURING USE, IT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE DAMAGE SUSTAINED BY THE RETURNED IMPACTOR TIPS, THE COMPLAINT CONDITION WAS CONFIRMED, BUT THE ROOT CAUSE WAS NOT CLEARLY RECOGNIZED. THE TECHNIQUE GUIDES FOR THE LCP AND DHS/DCS SYSTEMS SPECIFIES THAT THE IMPACTOR SHOULD BE USED USING LIGHT BLOWS AND THE PLATE BEING IMPLANTED SHOULD BE SEATED WITH THE IMPACTOR WITH THE WRENCH SHAFT LYING IN THE CHANNEL OF THE IMPACTOR. IF THE IMPACTOR IS NOT USED SPECIFICALLY AS DIRECTED THERE IS THE OPPORTUNITY FOR THE SOFT PLASTIC TIP OF THE IMPACTOR TO BE DAMAGED, WHICH SEEMS TO HAVE OCCURRED WITH THE RETURNED IMPACTOR TIPS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A TIP BROKE WHEN A SURGEON WAS IMPACTING A SIDE PLATE INTO HIP. SURGEON HAD TO SEARCH FOR THE PIECE, BUT HOSPITAL CONTACT WAS UNSURE OF A DELAY. THERE WERE TWO ADDITIONAL TIPS REPORTED, BUT THE ENDS WERE CHEWED UP AND WERE NOT USED. X-RAYS WERE TAKEN IN SURGERY AND IT WAS CONFIRMED NO PIECES REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. THIS REPORT IS FOR ONE OF THE IMPACTORS NOT USED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629238 TIP FOR DHS®/DCS® IMPACTOR (338.28) IMPACTOR HWA SYNTHES JENNERSVILLE 7137618

    Patients

    Seq Age Sex Outcome Treatment
    1