BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER

    MDR report key: 4197185 · Received October 23, 2014

    Report

    Report Number
    1719045-2014-10537
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: GREATBATCH MEDICAL MANUFACTURED THE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER, P/N 357.406, AND LOT #6150076 (SUPPLIER LOT #6286520001) ON PO #(B)(4) FOR (B)(4) PIECES DELIVERED MAY 20, 2009. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED MAY 27, 2009, AND SYNTHES FINAL INSPECTION SHEET #(B)(4), REVISION ¿K¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 2, 2009. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER WAS MADE TO THE SYNTHES DRAWING P/N 357.406, REVISION ¿D¿, RELEASED ON NOVEMBER 24, 2008. A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER BELONGS TO THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM AND IS USED FOR ENGAGING THE LOCKING MECHANISM OF THE NAIL THROUGH THE CANNULATED CONNECTING SCREW, AS WELL AS FOR INSERTING THE END CAP. THE TECHNIQUE GUIDE WAS REVIEWED FOR THE APPROPRIATE USE OF THIS DEVICE (J3900-I). ONE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER (PART # 357.406, SUPPLIER LOT # 6286520001, LOT # 6150076, MFG MAY2009) WAS RETURNED WITH THE COMPLAINT THAT ¿A FLEXIBLE HEX SCREWDRIVER BENT AND BROKE OFF WHILE THE SURGEON WAS TRYING TO ENGAGE THE TFN LOCKING MECHANISM. THE BROKEN PIECE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION¿. UPON RECEIPT IT WAS SEEN THAT THE BENDABLE SHAFT CONTAINS TWO MINOR BENDS, HOWEVER THE REMAINDER OF THE DEVICE IS INTACT, AND NO PIECES ARE MISSING. THIS COMPLAINT IS UNCONFIRMED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE 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 DURING INTRA-OPERATIVE SURGERY FOR AN INTERTROCHANTERIC HIP FRACTURE REQUIRING AN IMPLANT OF AN INTRAMEDULLARY NAIL ON 09/21/2014, THAT A FLEXIBLE HEX SCREWDRIVER BENT AND BROKE OFF WHILE THE SURGEON WAS TRYING TO ENGAGE THE TROCHANTERIC FIXATION NAIL (TFN) LOCKING MECHANISM. THE BROKEN PIECE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A TEN MINUTE TIME EXTENSION IN SURGERY AND NO REPORTS OF HARM TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675636 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER SCREWDRIVER HXX SYNTHES MONUMENT 6286520001

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR