BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 4335913 · Received December 17, 2014

    Report

    Report Number
    9612488-2014-10565
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 17, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE FLEXIBLE REAMERS BROKE. THE REPAIR TECHNICIAN REPORTED THE ITEM WAS MISSING PARTS. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: THE RETURNED FLEXIBLE SHAFT CONNECTOR, LOT NUMBER 5102047 (SUPPLIER LOT NUMBER 2151999), WAS MANUFACTURED OCTOBER, 2005. THE DEVICE WAS RECEIVED WITH THE COMPONENTS DISASSEMBLED AND ONE SPRING, TWO PINS, AND ONE WASHER WERE NOT RETURNED FOR EVALUATION. THE HEAD OF THE SET SCREW IS RETAINED IN THE CAP SLEEVE AND THE DISTAL PORTION IS BROKEN OFF AND WAS NOT RETURNED. THERE IS SIGNIFICANT WEAR ON THE PROXIMAL JACOBS CHUCK CONNECTING POST AND TO THE SLOT THAT MATES WITH THE SET SCREW. THE REMAINDERS OF THE DEVICE SHOWS ONLY SURFACE SCRATCHES WHICH APPEAR TO BE CONSISTENT WITH WEAR FROM NORMAL USE. THE COMPLAINT CONDITION IS CONFIRMED BUT CANNOT BE REPLICATED BECAUSE THE SET SCREW IS ALREADY BROKEN. THE DEVICE WAS MANUFACTURED AFTER THE RELEASE OF THE CURRENT DRAWING REVISION. THEREFORE, A REVIEW OF THE CURRENT DESIGN DRAWINGS, 651_16J REV. C AND SE_108607 REV. A, WAS PERFORMED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED AND THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE. THE COMPLAINT CONDITION WAS DETERMINED TO NOT BE THE RESULT OF A DESIGN DEFICIENCY. THE BROKEN SET SCREW AND THE SIGNIFICANT WEAR TO THE SLOT THAT MATES WITH THE SET SCREW IS CONSISTENT WITH THE RESULT FROM EXCESSIVE FORCE OVER ITS EXTENDED LIFETIME OF OVER 9 YEARS. IF A SET SCREW IS BROKEN THEN THE ASSEMBLY WILL NOT BE PROPERLY RETAINED. THUS, ALTHOUGH THE EXACT CAUSE OF THIS COMPLAINT CONDITION CANNOT BE DETERMINED DUE TO A LACK OF TECHNIQUE RELATED INFORMATION, THE METHOD OF USE AND MAINTENANCE OF THE DEVICE LIKELY LED TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THE EVALUATION WAS CONFIRMED. 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 DURING LATERAL ENTRY FEMORAL RECON NAIL SURGERY IN THE MIDDLE OF REAMING THE FEMORAL CANAL THE FLEXIBLE SHAFT CONNECTOR FOR THE JACOBS CHUCK BROKE AND WOULD NO LONGER HOLD THE REAMER. THERE WAS APPROXIMATELY A 2-MINUTE DELAY WHILE ANOTHER CONNECTOR WAS OBTAINED, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO FURTHER COMPLICATIONS. X-RAYS TAKEN AS PART OF THE PROCEDURE DID NOT SHOW ANY FRAGMENTS PRESENT IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828435 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER HTO SYNTHES BETTLACH 5102047

    Patients

    Seq Age Sex Outcome Treatment
    1