BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH MINI QUICK COUPLING

    MDR report key: 6016873 · Received October 11, 2016

    Report

    Report Number
    2530088-2016-10286
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Report Date
    September 21, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WAS COMPLETED FOR PART # 311.01, LOT # 5083479. ONE HANDLE WITH MINI QUICK COUPLING WAS RETURNED FOR MANUFACTURING INVESTIGATION/EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED HANDLE IS USED IN SCREW INSERTION AND REMOVAL ACROSS MULTIPLE PLATING SYSTEMS SUCH AS THE MODULAR FOOT, THE MODULAR HAND, AND THE DISTAL ULNA SYSTEMS. IT WAS REPORTED THAT THE HANDLE WAS FOUND TO BE BROKEN DURING A FIELD EQUIPMENT REVIEW BY THE SALES CONSULTANT. THIS CONDITION IS CONFIRMED AS, UPON RECEIPT, THE HANDLE WAS NOTED TO BE SEPARATED FROM THE SHAFT OF THE DEVICE AND IN THREE PIECES. APPROXIMATELY HALF OF THE DISTAL 14MM OF THE HANDLE WAS NOTED TO BE MISSING. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND IS IN FUNCTIONAL CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS HANDLE COULD NOT BE RELEASED. DHR REVIEW: DEVICE HISTORY RECORD REVIEW FOR PART 311.01, LOT # 5083479 REVEALED THAT MATERIAL REVIEW RECORD (MRR) WAS GENERATED ON PART 311.01.96 LOT 5083479. UPON INSPECTION OF THE (B)(4) HANDLE FOR MINI QUICK COUPLING THAT WERE PROCESSED IN (B)(4) ON 09/27/2005, (B)(4) WERE INSPECTED AND 1 WAS FOUND THAT THE LOCK/UNLOCK FUNCTION WAS REJECTED AND SCRAPPED. LOCK/UNLOCK FUNCTION IS NOT RELEVANT TO THE COMPLAINT CONDITION REPORTED. THE RELEVANCE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR THE HANDLE AND THE HANDLE COMPONENT WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED GIVEN THE UNKNOWN CONDITIONS OVER THE 11 YEAR LIFESPAN OF THE DEVICE. HOWEVER, THE COMPLAINT CONDITION IS TYPICALLY ASSOCIATED REPETITIVE ROUGH HANDLING AND STERILIZATION CYCLES (THERMAL CYCLING) OVER THE LIFE OF THE DEVICE. INFORMATION ON CARE AND MAINTENANCE IS PROVIDED PER THE PROCESSING SYNTHES REUSABLE MEDICAL DEVICES ¿ INSTRUMENTS, INSTRUMENT TRAYS, AND CASES. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORD REVIEW FOR PART 311.01, LOT # 5083479 REVEALED THAT MATERIAL REVIEW RECORD (MRR) WAS GENERATED ON PART 311.01.96 LOT 5083479. UPON INSPECTION OF THE (B)(4) HANDLE FOR MINI QUICK COUPLING THAT WERE PROCESSED IN (B)(4) ON 09/27/2005, (B)(4) WERE INSPECTED AND 1 WAS FOUND THAT THE LOCK/UNLOCK FUNCTION WAS REJECTED AND SCRAPPED. LOCK/UNLOCK FUNCTION IS NOT RELEVANT TO THE COMPLAINT CONDITION REPORTED. THE RELEVANCE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REVIEWING THE FIELD EQUIPMENT, IT WAS NOTED THAT THE HANDLE ON THE MINI QUICK COUPLING INSTRUMENT WAS BROKEN IN PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667784 HANDLE WITH MINI QUICK COUPLING TAP,BONE HWX SYNTHES BRANDYWINE 5083479

    Patients

    Seq Age Sex Outcome Treatment
    1