BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURNING HANDLE F/90 SCRWDRVR

    MDR report key: 12031853 · Received June 21, 2021

    Report

    Report Number
    8030965-2021-05109
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    10887587013312
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. D4, D9, H3, H4, H6: PART # 03.505.005, LOT # 8182684. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(6). RELEASE TO WAREHOUSE DATE: 05 JULY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT TURNING HANDLE F/90 SCRWDRVR HAS SOME SLIGHT SCRATCHES AND NICKS WHICH DOESN¿T AFFECT THE FUNCTIONALITY. NO OTHER ISSUES WERE FOUND ON THE DEVICE. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE NATURE OF THE COMPLAINT ALLEGATION. THE RETURNED COMPONENTS OF THE DEVICE WERE ABLE TO ASSEMBLE/DISASSEMBLE AS INTENDED BUT THE OVERALL FUNCTIONAL TEST OF THE DEVICE WAS NOT PERFORMED AS NOT ALL MATING DEVICES WERE RETURNED. THE ALLEGED UNABLE TO ASSEMBLE CONDITION CANNOT BE CONFIRMED SINCE THE DEVICE WAS ABLE TO BE ASSEMBLED. THE OBSERVED UNABLE TO ASSEMBLE IS NOT CONSISTENT WITH THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR TURNING HANDLE F/90 SCRWDRVR SINCE THE DEVICE WAS ABLE TO BE ASSEMBLED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION 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. DRAWING/SPECIFICATIONS REVIEWED? THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: -TURNING HANDLE FOR SCREW DRIVER 90. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) TURNING HANDLE F/90 SCRWDRVR. THIS REPORT IS 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928404 TURNING HANDLE F/90 SCRWDRVR SCREWDRIVERS HXX SYNTHES GMBH 03.505.005 8182684 10887587013312

    Patients

    Seq Age Sex Outcome Treatment
    1 HAND| HAND| INSTR F/REMOVAL OF INSERTS| SCR-HOLDER W/O INSERT| SCR-HOLDER W/O INSERT| SHAFT| SHAFT| TURNING HANDLE| UNK - HANDLES: TRAUMA| HAND| HAND| INSTR F/REMOVAL OF INSERTS| SCR-HOLDER W/O INSERT| SCR-HOLDER W/O INSERT| SHAFT| SHAFT| TURNING HANDLE| UNK - HANDLES: TRAUMA