BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE

    MDR report key: 6955052 · Received October 17, 2017

    Report

    Report Number
    3000270450-2017-10363
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 22, 2017
    Report Date
    September 22, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT WAS REPORTED AS 5 FEET 3 INCHES. BMI: 19.1. 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

    (B)(4). DEVICE IS NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440, LOT # 160187-101, QUANTITY # 1). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW PART # 04.034.240S LOT # 7313389 SERIAL/SUPPLIER LOT # 7313389 PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4) MANUFACTURING DATE: 04.APR.2013 EXPIRY DATE: 28. FEB. 2022 NO NCRS 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. NON-STERILE (B)(4) WAS MANUFACTURED IN US, (B)(4). 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 A SUPRAPATELLAR TIBIAL NAILING ON (B)(6) 2017, INSTRUMENTS MALFUNCTIONED. AFTER THE NAIL WAS IMPLANTED, AND THE INTERLOCKING SCREWS WERE IMPLANTED SUCCESSFULLY, THE INSERTION HANDLE/CONNECTING BOLT WOULD NOT UNSCREW FROM THE NAIL. THE SCREWS AND NAIL WERE REMOVED, THE CONNECTION WAS INSPECTED AND WE FOUND THAT THE CONNECTION UNSCREWED SUCCESSFULLY. THE NAIL AND SCREWS WERE RE-IMPLANTED ONLY TO FIND THE SAME PROBLEM. AT THAT TIME A POSTERIOR ROTATIONAL FORCE WAS PLACED ON THE POUNDING CAP TO ALLOW THE INSERTION HANDLE/CONNECTING BOLT TO FINALLY UNSCREW. THE NAIL REMAINS IMPLANTED. IN ADDITION, THE SLOTTED MALLET IS NOT FUNCTIONAL. THE TOP PORTION OF THE MALLET DIDN¿T TOGGLE AS IT SHOULD. AS A RESULT OF ALL OF THESE ISSUES, THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO ADVERSE EVENTS OCCURRED AND NO UNANTICIPATED X-RAYS WERE NEEDED. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440, LOT # 160187-101, QUANTITY # 1) THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734445 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES SELZACH 7313389

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR