BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 7856132 · Received September 7, 2018

    Report

    Report Number
    2939274-2018-53660
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 21, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982068965
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. PART: 03.010.475. LOT: L361938. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 12.MAY.2017. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 48 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND MATERIAL HARDNESS CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CQ OBSERVED THAT THE PARTIALLY-THREADED DISTAL TIP PORTION OF THE DRIVING CAP FRACTURED/BROKE AT ITS BASE. THE BROKEN PORTION WAS RETURNED RETAINED IN THE RETURNED CONCOMITANT INSERTION HANDLE (PRODUCT CODE: 03.010.440, LOT #: 170319-010, QUANTITY: 1) AND WAS UNABLE TO BE REMOVED FROM THE INSERTION HANDLE. NO ISSUES WERE IDENTIFIED ON BOTH THE INSERTION HANDLE AND THE REMAINING PORTIONS OF THE DRIVING CAP EXCEPT FOR THE SIGNS OF HAMMER MARKS ON THE DRIVING CAP¿S HEAD, INCLUDING THE UNDERSIDE OF THE HEAD; THESE MARKS DO NOT AFFECT THE PRODUCT¿S FUNCTIONALITY. HAMMER MARKS ON THE UNDERSIDE OF THE HEAD INDICATE THE DRIVING CAP MAY HAVE EXPERIENCED OFF-AXIS FORCES. BASED ON VISUAL INSPECTION, THE COMPLAINT CONDITION AGREES WITH THE COMPLAINT DESCRIPTION - THE COMPLAINT CONDITION WAS CONFIRMED. THE INSERTION HANDLE WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION; NO ISSUES WERE IDENTIFIED DURING VISUAL INSPECTION. THEREFORE, NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE BROKEN FEATURE COULD NOT BE CONDUCTED AS IT COULD NOT BE RETRIEVED/DISASSEMBLED FROM THE INSERTION HANDLE. DOCUMENT/SPECIFICATION REVIEW: DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT INCLUDING THE MATERIALS AND ITS PROPERTIES, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A RELEVANT DRAWING FOR THE RETURNED DEVICE WAS REVIEWED DURING THE INVESTIGATION (THE DRAWING AT THE TIME OF MANUFACTURE IS CURRENT): DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION OF THE DRIVING CAP BREAKING OFF WITHIN THE INSERTION HANDLE WAS CONFIRMED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS LIKELY THAT ANY UNINTENDED OFF-AXIS FORCES ENCOUNTERED BY THE DEVICE DURING USAGE COULD HAVE CONTRIBUTED TO THE BROKEN TIP 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE: INSERTION HANDLE FOR SUPRAPATELLAR (PART: 03.010.440, LOT: 170319-010, QUANTITY: 1).

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT: 185.40 CMS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 DURING A SURGERY ON (B)(6) 2018, THE DRIVING CAP THREADS BROKE OFF IN THE INSERTION HANDLE FOR SUPRAPATELLAR WHILE AN UNKNOWN TIBIAL NAIL WAS BEING INSERTED FROM THE SUPRAPATELLAR ENTRY. THE SURGEON HAD TO USE THE HANDLE WITHOUT THE DRIVING CAP TO COMPLETE THE PROCEDURE DUE TO NO BACK UP DEVICE AVAILABLE. THERE WAS A 10 MINUTE SURGICAL DELAY REPORTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUES. CONCOMITANT DEVICE REPORTED: INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697765 DRIVING CAP MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC L361938 10886982068965

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR