BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 9147783 · Received October 2, 2019

    Report

    Report Number
    2939274-2019-61135
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    August 4, 2019
    Report Date
    September 12, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 DEVICES: HANDLE FOR 90 DEGREES SCREWDRIVER ( PART# 03.505.004, LOT #8172621, QUANTITY#1) AND INSTRUMENT TRAY FOR 90 DEGREES SCREWDRIVER ( PART# 60.505.003, LOT # LIFO14152, QUANTITY#1).

    Additional Manufacturer Narrative · 1

    OCCUPATION: SYNTHES EMPLOYEE. ADDITIONAL PRODUCT CODE: DZJ ,HXX. INVESTIGATION SUMMARY: VISUAL INSPECTION: THE SHAFT FOR 90 DEGREE SCREWDRIVER WAS RECEIVED AT THE US CQ. THE DEVICE WAS RECEIVED WITH THE SHAFT IN FRONT SUBCOMPONENT DISASSEMBLED FROM THE REST OF THE ASSEMBLY. THE SHAFT WITH HEAD SUBCOMPONENT HAD SURFACE SCRATCHES. THE HELICAL GEAR OF THE SHAFT IN FRONT WAS STRIPPED. NO OTHER ISSUES COULD BE IDENTIFIED WITH THE RETURNED PORTIONS OF THE DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED ON THE SHAFT FOR 90 DEGREE SCREWDRIVER. THE SHAFT IN FRONT SUBCOMPONENT WAS REASSEMBLED INTO THE SHAFT WITH HEAD SUBCOMPONENT. THE SHAFT IN FRONT WAS ABLE TO ROTATE THE GEARWHEEL SUBCOMPONENT SMOOTHLY BUT WAS FORCED OUTWARD AND BACK DURING A SINGLE REVOLUTION. THE SHAFT IN FRONT WAS SIMILARLY PUSHED IN AND OUT DURING A SINGLE ROTATION. THE DEVICE ALSO MADE A RELATIVELY LOUDER NOISE WHEN DOING SO. THIS ALL WAS MOST LIKELY DUE TO THE DAMAGE TO THE HELICAL GEAR OF THE SHAFT IN FRONT. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. MANUFACTURING RECORD EVALUATION: THE RECEIVED DEVICE (PART # 03.505.003 LOT # 8173333) WAS MANUFACTURED AT THE (B)(4) SITE ON OCTOBER 27, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE SHAFT FOR 90 DEGREE SCREWDRIVER. THE DEVICE WAS RECEIVED PARTIALLY DISASSEMBLED. THE DEVICE, HOWEVER, DID NOT FALL APART BECAUSE THE SEPARATED SUBCOMPONENTS WERE INTENDED TO BE DISASSEMBLED FOR STERILIZATION AND STORAGE PROCEDURES. THE SHAFT WITH HEAD WAS SCRATCHED. THE SHAFT IN FRONT SUBCOMPONENT WAS REASSEMBLED INTO THE SHAFT WITH HEAD, AND THE GEARWHEEL SUBCOMPONENT WAS ABLE TO BE SMOOTHLY ROTATED. HOWEVER, DURING THE ROTATION OF THE SHAFT IN FRONT, THE GEARWHEEL AND SHAFT IN FRONT WOULD BE PUSHED IN AND OUT OF PLACE. THE DEVICE ALSO MADE A RELATIVELY LOUDER NOISE WHEN DOING SO. THIS ALL WAS MOST LIKELY DUE TO THE DAMAGE TO THE HELICAL SCREW OF THE SHAFT IN FRONT INTERRUPTING THE ROTATION. THE LOOSE SUBCOMPONENTS DID NOT CAUSE THE DEVICE TO FALL APART, ONLY WRIGGLE IN PLACE. THE DEVICE FUNCTIONALITY WITH A SCREW WAS NOT TESTED SINCE AN ASSOCIATED SCREW WAS NOT RETURNED WITH THE DEVICE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, BUT THE DEVICE MOST LIKELY ENCOUNTERED UNINTENDED FORCES. 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. DEVICE HISTORY LOT: PART: 03.505.003, LOT: 8173333, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: OCT. 27, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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, BOTH HANDLE FOR 90 DEGREE SCREWDRIVERS GEAR HEADS WERE MAKING SLIGHT GRINDING NOISES AND EVENTUALLY CAUSED THE GEAR LID TO POP OUT THE BACK SIDE OF THE GEAR HEAD. THE CAUSE OF INTERNAL DISRUPTION IS UNSURE. THE SURGEON DECIDED TO SWITCH TECHNIQUES WHEN THIS EVENT OCCURRED. THIS COMPLAINT OCCURRED DURING IMPLANT. THERE IS NO REVISION OR REMOVAL, THIS CASE WAS THE FIRST RIB ORIF. PATIENT WAS NOT EFFECTED BY THE INCIDENT AND NO ADDITIONAL TIME WAS ADDED TO THE SURGERY. CONCOMITANT DEVICE REPORTED: HANDLE FOR 90° SCREWDRIVER (PART# 03.505.004 , LOT # UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941312 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.003 8173333 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HANDLE FOR 90° SCREWDRIVER| HANDLE FOR 90° SCREWDRIVER| INSTRUMENT TRAY FOR 90° SCREWDRIVER| LID FOR INSTRUMENT TRAY FOR 90° SCREWDRIVER