BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 8887581 · Received August 13, 2019

    Report

    Report Number
    2939274-2019-59760
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Report Date
    July 18, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034714882
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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. H3, H4, H6: THE HOLDING SLEEVE (P/N 03.614.017, LOT # T151708) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THREADS OF THE DEVICE SHOWED NO SIGNS OF STRIPPING OR DAMAGE. THIS IS NOT CONSISTENT WITH THE REPORTED COMPLAINT CONDITION. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. A FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE HOLDING SLEEVE WAS RETURNED BY ITSELF. ALSO, THERE WERE NO VISUAL DEFECTS FOUND. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED, THEREFORE, THE COMPLAINT IS NOT CONFIRMED. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE OUTER THREADED DIAMETER OF THE SHAFT WAS MEASURED TO BE 7.39 MM (CALIPER CA818). THIS IS WITHIN SPECIFICATION OF 7.35 MM ± 0.05, BASED ON DRAWING: 03_614_017_1, REV. C. BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. SPRING LOADED THREADED DRIVER SLEEVE: 03_614_017, REV. F/G INNER SLEEVE THREADED DRIVER SLEEVE: 03_614_017_1, REV C THE COMPLAINT CONDITION IS NOT CONFIRMED AS HOLDING SLEEVE (P/N 03.614.017, LOT # T151708) SHOWED NO SIGNS OF STRIPPED/ DAMAGED THREADS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. PART NUMBER: 03.614.017 LOT NUMBER: T151708 MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: 02-MAY-2017 A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 (B)(6) 2019, DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SETS, THE FOUR (4) THREADED HOLDING SLEEVE WERE ALL HAVE DAMAGED THREADS WHICH MAKE THREADING ON TO SCREW IMPLANT DIFFICULT. THE GRAY TOP OF THE TWO (2) HANDLE FOR HOOK OR SCREW HAS COME OFF. ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING OF THE SCREW THAT HOLDS THE INSTRUMENT TOGETHER WAS MISSING. ONE (1) ROD INTRODUCTION PLIERS SET SCREW SECURING THE SLEEVE ON THE TUBE WAS MISSING. THE SPRING IN ONE (1) OF THE SOCKET WRENCH WITH STRAIGHT WON'T HOLD THE NUT IMPLANT. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: TITANIUM NUT IMPLANT (PART# 498.003, LOT#UNKNOWN, QUANTITY 1). THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680746 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.614.017 T151708 10705034714882

    Patients

    Seq Age Sex Outcome Treatment
    1 TI NUT 11MM WIDTH ACROSS FLATS