BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 7222940 · Received January 26, 2018

    Report

    Report Number
    2939274-2018-50412
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Report Date
    September 1, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982068569
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS AN UNKNOWN DATE IN (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. PART 03.010.404, LOT U253051: RELEASE TO WAREHOUSE DATE: DECEMBER 08, 2016. SUPPLIER: (B)(4). 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 THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: PER THE TECHNIQUE GUIDE, THE CONNECTING SCREW FOR SUPRAPATELLAR (03.010.404) IS A COMPONENT OF THE SUPRAPATELLAR INSERTION INSTRUMENT SET (01.004.305) AND A COMPONENT OF THE SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TIBIAL NAIL SYSTEM. IN USE, THE CONNECTING SCREW IS INSERTED THOROUGH THE HANDLE AND THREADED INTO THE PROXIMAL END OF THE NAIL. THE NAIL CAN THEN BE INSERTED WITH LIGHT, CONTROLLED HAMMERING ON A DRIVING CAP ATTACHED TO THE INSERTION HANDLE. FOLLOWING INSERTION AND BOTH DISTAL AND PROXIMAL LOCKING, THE CONNECTING SCREW CAN BE UNTHREADED FROM THE NAIL AND THE HANDLE REMOVED. THE RETURNED DEVICE WAS EXAMINED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIABLE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION. THE CONNECTING SCREW DISTAL THREADS, WHICH ENGAGE WITH THE TIBIAL NAIL, ARE IN GOOD CONDITION WITH NO DEFORMATION. AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION, THE COMPLAINT IS UNCONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH CURRENT AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS APPLICABLE AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS AND NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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 ON AN UNKNOWN DATE IN (B)(6) 2017, THE CONNECTING SCREW WAS VERY DIFFICULT TO DISCONNECT FROM THE TIBIAL NAIL DURING A TIBIAL NAIL PROCEDURE WITH SUPRAPATELLAR APPROACH. THE CONNECTING SCREW WAS STUCK ON THE NAIL AND THE SURGEON USED A CANNULATED SHAFT WITH AN 8MM HEX ALONG WITH A RATCHET WRENCH TO DISCONNECT THE CONNECTING SCREW. THE NAIL REMAINED IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AN APPROXIMATE FIVE TO TEN-MINUTES SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE PATIENT WAS REPORTED TO BE STABLE. CONCOMITANT DEVICES REPORTED: CANNULATED SHAFT WITH 8MM HEX 125MM (PART # 357.398, LOT # UNKNOWN, QUANTITY 1); RATCHET WRENCH-11MM WIDTH ACROSS FLATS (PART # 321.20, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66229 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC U253051 10886982068569

    Patients

    Seq Age Sex Outcome Treatment
    1