BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 4664520 · Received April 7, 2015

    Report

    Report Number
    2530088-2015-10107
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    March 21, 2015
    Report Date
    March 24, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE USED IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. DEVICE 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 338.26, LOT NUMBER 6082664, TIP FOR DHS/DCS IMPACTOR). THE 338.26 TIP FOR DHS/DCS IMPACTOR IS PART OF AN INSTRUMENT ROUTINELY USED IN THE DHS/DCS DYNAMIC HIP AND CONDYLAR SCREW SYSTEM PER THE TECHNIQUE GUIDE. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN WHILE IMPACTING THE SIDE PLATE. THIS CONDITION IS CONFIRMED; A LARGE CHUNK OF THE IMPACTOR TIP HAS BROKEN OFF FROM THE DEVICE LEAVING AN IRREGULAR FRACTURE SURFACE FROM THE MOST DISTAL TIP TO ABOUT HALF THE LENGTH OF THE DEVICE. IT IS LIKELY THAT ROUGH HANDLING AND HAMMERING OVER SIX YEARS OF USE HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED DURING APRIL 2009 AND IS OVER SIX YEARS OLD. THE BALANCE OF THE RETURNED MY DEVICE IS IN WORN THOUGH WORKING CONDITION. THE SUBJECT DEVICE DRAWING WAS REVIEWED AND IT WAS DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. THE COMPLAINT CONDITION FOR THE 338.26 LOT NUMBER 6082664 TIP FOR DHS/DCS IMPACTOR WAS LIKELY CAUSED BY ROUGH HANDLING AND HAMMERING OVER SIX YEARS OF USE; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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

    A SERVICE HISTORY REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE LOT 6082664. A SERVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 17-APR-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.A SERVICE EVALUATION WAS ALSO PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE GREY END BROKE WHEN IMPACTING THE PLATE. THE REPAIR TECHNICIAN REPORTED ¿TIP BROKEN¿ AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE SYNTHES COMPLAINT HANDLING UNIT FOR ADDITIONAL EVALUATION. THE SERVICE EVALUATION WAS CONFIRMED.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 THAT THE 17.0MM/3.2MM WIRE GUIDE WOULD NOT FIT THROUGH THE INSERT FOR TROCHANTERIC FIXATION NAIL (TFN) DURING A SURGICAL PROCEDURE. ADDITIONALLY, THE TIP OF THE DYNAMIC HIP SCREW/DYNAMIC COMPRESSION SCREW (DHS/DCS) BROKE AT THE GREY END WHEN IMPACTING THE PLATE. A TEN (10) MINUTE SURGICAL DELAY WAS NOTED, BUT NO PATIENT HARM ASSESSED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229218 TIP FOR DHS®/DCS® IMPACTOR (338.28) IMPACTOR HWA SYNTHES BRANDYWINE 6082664

    Patients

    Seq Age Sex Outcome Treatment
    1