BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE/SCREW GUIDE SLEEVE

    MDR report key: 9832947 · Received March 14, 2020

    Report

    Report Number
    2939274-2020-01279
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Report Date
    February 17, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982070333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4: LOT H3, H4, H6: PART NUMBER: 03.037.016 LOT NUMBER: 9872394 PER JDE, MANUFACTURED DATE: 06/30/2016 A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE NO MANUFACTURING RECORD EVALUATION IS REQUIRED. VISUAL INSPECTION: THE BUTTRESS/COMPRESSION NUT (P/N: 03.037.016, LOT #: 9872394) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). THE BUTTRESS NUT APPEARS TO BE IN GOOD CONDITION, THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: THERE WERE TWO BLADE/SCREW GUIDE SLEEVE (P/N: 03.037.017) RECEIVED AT US CQ. THE DEVICE WAS ABLE TO ASSEMBLE WITH ONE BLADE/SCREW GUIDE SLEEVE. THE BUTTRESS NUT WAS ABLE TO SUCCESSFULLY SECURE ONTO THE THREADS OF ONE SLEEVE AND CAN ROTATE CLOCKWISE AND ANTI-CLOCKWISE AS DESIGNED BUT WAS UNSUCCESSFUL TO SECURE FULLY ONTO THE THREADS OF THE GUIDE SLEEVE WITH DEFORMATION. THE BLADE/SCREW GUIDE SLEEVE WITH DEFORMATION WAS INVESTIGATED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? NO, THERE WERE NO FUNCTIONAL ISSUES IDENTIFIED WITH THE RETURNED DEVICE THAT COULD HAVE CAUSED THE DEVICE INTERACTION. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS ABLE TO SUCCESSFULLY ASSEMBLE WITH ONE BLADE/SCREW GUIDE SLEEVE THAT HAD NO ISSUE, AND THERE WAS NO OTHER DAMAGE BESIDES LIGHT COSMETIC DAMAGE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED - BUTTRESS/COMPRESSION NUT COMPLAINT CONFIRMED? NO, THE DEVICE WAS ABLE TO ASSEMBLE WITH ONE GUIDE SLEEVE AND THERE WERE NO FUNCTIONAL ISSUES IDENTIFIED WITH THE RETURNED DEVICE THAT COULD HAVE CAUSED THE DEVICE INTERACTION. THE DEFORMATION ON THE MATING DEVICE WAS IDENTIFIED AS THE ROOT CAUSE FOR THE COMPLAINT CONDITION OF UNABLE TO ASSEMBLE. AND IS BEING INVESTIGATED. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS UNCONFIRMED FOR THE BUTTRESS/COMPRESSION NUT (P/N: 03.037.016, LOT #: 9872394). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE. THE DEFORMATION ON THE MATING DEVICE WAS IDENTIFIED AS THE ROOT CAUSE FOR THE COMPLAINT CONDITION OF UNABLE TO ASSEMBLE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H11 CORRECTED DATA: D4: UNIQUE IDENTIFIER( UDI). 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

    THIS REPORT IS 1 OF 5 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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, THE BLADE SCREW GUIDE SLEEVE AND INSERTS (BUTTRESS/COMPRESSION NUT, WIRE GUIDE SLEEVE AND TROCAR) ARE STICKING AND HAVING A DIFFICULT TIME ASSEMBLING. THE STERILE PROCESSING DEPARTMENT (SPD) WAS CONCERNED ABOUT FUNCTION AND USAGE DUE TO ASSEMBLING AND PROPER FUNCTION DURING A CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) BLADE/SCREW GUIDE SLEEVE. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296149 BLADE/SCREW GUIDE SLEEVE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.017 9872394 10886982070333

    Patients

    Seq Age Sex Outcome Treatment
    1