BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 5920768 · Received September 1, 2016

    Report

    Report Number
    9612488-2016-10359
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 16, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRIVING CAP/THREADED, PART NUMBER 03.010.523, LOT NUMBER 9065773). THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT REPORTING THE THREADS BROKE OFF INTO THE HAMMER GUIDE CONNECTOR INTRAOPERATIVELY WITH NO SURGICAL DELAY. THE 03.010.523 DRIVING CAP IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED TIBIAL NAILS SYSTEM PER THE ASSOCIATED TECHNIQUE GUIDE. THE DRIVING CAP WAS RETURNED WITH THE DISTAL THREADS BROKEN OFF AND LODGED IN THE RETURNED HAMMER GUIDE CONNECTOR (PART 03.037.120, LOT 9202547). THE DRIVING CAP ALSO SHOWED SIGNS OF WEAR AND IMPACTION ALONG THE SHAFT AND PROXIMAL END. THE PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. 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. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS CONFIRMED, ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED. THE DAMAGE TO THE DRIVING CAP HOWEVER IS MOST LIKELY THE RESULT OF OFF-AXIS HAMMERING ON THE DEVICE BEFORE FULLY SEATING THE DRIVING CAP ON THE INSERTION HANDLE OR FROM CROSS THREADING THE DEVICE. 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

    (B)(6) PATIENT WEIGHT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 28, 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO 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 IS REPORTED DURING A TROCHANTERIC PROXIMAL FEMORAL NAIL-ADVANCED (TFNA) PROCEDURE ON (B)(6) 2016, SURGEON WAS PLACING THE NAIL. WITH THE NAIL ALMOST IN THE DESIRED POSITION, SURGEON USED THE HAMMER ON THE DRIVING CAP PER THE TECHNIQUE GUIDE. AS HE DID SO, THE DRIVING CAP BROKE OFF AT THE THREADS AND FELL TO THE FLOOR. THE THREADS FROM THE DRIVING CAP REMAIN STUCK INSIDE THE HAMMER GUIDE CONNECTOR. BECAUSE THE NAIL WAS ALMOST TO ITS DESIRED POSITION, SURGEON USED ANOTHER INSTRUMENT TO GENTLY TAP THE NAIL IN PLACE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. THAT PATIENT STATUS WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: SPIRAL COMBINATION HAMMER (PART 03.010.522, LOT UNKNOWN, QUANTITY 1), THREADED HAMMER GUIDE CONNECTOR (PART 03.037.120, LOT 9202547, QUANTITY 1), INSERTION HANDLE (PART AND LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571917 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 9065773

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR SPIRAL COMBINATION HAMMER (03.010.522)| THREADED HAMMER GUIDE CONNECTOR (03.037.120)| UNKNOWN INSERTION HANDLE