BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 9078738 · Received September 17, 2019

    Report

    Report Number
    2939274-2019-60648
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    August 19, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H3, H6: INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED WHILE INSPECTING THE INTER- LOCK SCREWDRIVER, IT WAS NOTICED STRIPPED AND WILL NOT HOLD A SCREW ON THE TIP OF IT. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THE REPAIR TECHNICIAN REPORTED THAT THE TIP OF THE SCREWDRIVER AND THE SLIDER ARE TWISTED/BENT/DAMAGED. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. VISUAL INSPECTION: THE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM (PART # 03.010.473 LOT # 7860754) WAS RECEIVED AT US CQ. THE DEVICE WAS RECEIVED DISASSEMBLED. THE DISTAL TIPS OF BOTH THE SHAFT, SD25/3.5MM HEX (03.010.473.1) AND THE SLIDING BAR, SD25/3.5MM HEX (03.010.473.2) ARE TWISTED IN THE DIRECTION OF TIGHTENING. THE TIPS ARE ALSO BENT IN THE DIRECTION OF TIGHTENING. THE TIPS ARE BENT ENOUGH THAT ASSEMBLY OF THE DEVICE IS NOT POSSIBLE. THE SLIDING BAR NO LONGER PROPERLY ALIGNS WITH THE SHAFT. THE TWO COMPONENTS CANNOT COMPLETELY MATE TOGETHER. THERE IS SURFACE WEAR ON THE HANDLE AND SOME DISCOLORATION. IT APPEARS THAT THERE IS SOME RESIDUE ON THE DISTAL END OF THE HANDLE, IT APPEARS THE DEVICE HAD TAPE APPLIED TO IT. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. DEVICE DISTAL TIP IS TWISTED AND BENT IN THE DIRECTION OF TIGHTENING. IT IS NOT POSSIBLE TO ASSEMBLE THE DEVICE THUS IT IS INOPERABLE. DIMENSIONAL INSPECTION: DUE TO THE DAMAGE ON THE DISTAL TIP, DIMENSIONAL INSPECTION ON THE TIP FEATURE WAS NOT POSSIBLE. THE FEATURES JUST PROXIMAL TO THE TIP WERE MEASURED INSTEAD. SPECIFIED DIMENSIONS: SHAFT DIAMETER [SHAFT] = 6.4MM +/- 0.02MM. GAP WIDTH [SHAFT] = 4.8MM + 0.1MM / - 0.0MM. WIDTH [SLIDING BAR] = 4.5MM + 0.0MM / - 0.1MM. MEASURED DIMENSIONS: SHAFT DIAMETER [SHAFT] = 6.38MM; CONFORMING. GAP WIDTH [SHAFT] = 4.80MM; CONFORMING. WIDTH [SLIDING BAR] = 4.46MM; CONFORMING. DEVICE(S) USED: CA215P. MANUFACTURING RECORD EVALUATION: THE RECEIVED INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM (PART # 03.010.473 LOT # 7860754) WAS MANUFACTURED AT THE HAEGENDORF SITE ON APR 05, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE RECEIVED INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM (PART # 03.010.473 LOT # 7860754) AS THE DISTAL TIP OF THE DEVICE IS TWISTED AND BENT IN THE DIRECTION OF TIGHTENING, AND IS NOT POSSIBLE TO ASSEMBLE. THE DEVICE IS INOPERABLE DUE TO THE OBSERVED DAMAGE. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE EXPERIENCED UNINTENDED FORCES DURING USE SUCH AS OVER-TORQUE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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: 03.010.473, LOT: 7860754, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: APR. 05, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. AWARENESS DATE REPORTED ON FOLLOW UP 1 REPORT AS 08/19/2019 BUT SHOULD HAVE BEEN 10/4/2019. 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

    OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. 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 WHILE INSPECTING THE INTER- LOCK SCREWDRIVER ON AN UNKNOWN DATE, IT WAS NOTICED TO BE STRIPPED AND WILL NOT HOLD A SCREW ON THE TIP OF IT. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871310 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.473 7860754 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: TRAUMA