BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    MDR report key: 6371049 · Received March 1, 2017

    Report

    Report Number
    3003875359-2017-10095
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 3, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982069047
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT INVESTIGATION WAS PERFORMED FOR THE RETURNED SUBJECT DEVICE (RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM, PART NUMBER 03.010.486, LOT NUMBER 9102618). THE SUBJECT DEVICE WAS RETURNED WITH A SMALL PIECE OF THE DRIVING CAP STUCK INSIDE IT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE DATE: OCT 27, 2014. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE COMPLAINT AGAINST THE INSERTION HANDLE IS UNCONFIRMED AS THE BREAKAGE IS ISOLATED TO JUST THE DRIVING CAP. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. 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 DURING AN INTRAMEDULLARY TIBIAL NAIL PROCEDURE ON (B)(6) 2017, WHILE THE SURGEON WAS USING A MALLET, THE TIP OF THE DRIVING CAP BROKE OFF IN THE INSERTION HANDLE; THE SMALL PIECE IS STILL STUCK INSIDE THE INSERTION HANDLE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR SURGICAL DELAY. ANOTHER DRIVING CAP WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY WITH SUCCESSFUL PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: TIBIAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY); MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150390 RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 9102618 10886982069047

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR UNKNOWN MALLET, QUANTITY 1| UNKNOWN TIBIAL NAIL, QUANTITY 1