BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 4045341 · Received August 28, 2014

    Report

    Report Number
    3003787298-2014-10041
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 4, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE SERVICE AND REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN. 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 (B)(4) 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 ((B)(4)). 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 THE REPORT SHOULD HAVE INDICATED THE REQUIRED INTERVENTION OF X-RAY DURING SURGERY. 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

    THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED A REPORT FROM A CUSTOMER REGARDING 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 CONFIRMED NO PIECES REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525876 TIP FOR DHS®/DCS® IMPACTOR (338.28) IMPACTOR HWA SYNTHES JENNERSVILLE 7253826

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention