BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION SCREWDRIVER SELF-RETAINING

    MDR report key: 8522620 · Received April 17, 2019

    Report

    Report Number
    2939274-2019-57519
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 25, 2019
    Report Date
    March 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034769332
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 324.105. SYNTHES LOT # 6327282. SUPPLIER LOT # 617009N09. RELEASE TO WAREHOUSE DATE: 26 FEB 2010. SUPPLIER: TELEFLEX MEDICAL, INC. NO NCR'S WERE GENERATED DURING PRODUCTION. 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE TIP OF THE RETURNED SCREW DRIVER WAS WORN AT ITS EXTREME EDGES. NO NEW ISSUES WERE IDENTIFIED ON THE REMAINING PORTIONS OF THE DEVICE. FUNCTIONAL TEST: FUNCTIONAL TEST WAS NOT ABLE TO BE PERFORMED AS THE MATING DEVICE(SCREWS) WERE NOT RETURNED ALONG WITH THE COMPLAINED DEVICE AT CUSTOMER QUALITY. COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED AT THE CUSTOMER QUALITY AS THE MATING DEVICES WERE NOT RETURNED. HOWEVER DUE THE WORN CONDITION OF THE RETURNED DEVICES IT IS CONFIRMED THAT THE COMPLAINT CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION WAS CONFIRMED. DRAWING REVIEW: RELEVANT DRAWINGS FOR THE RETURNED DEVICE (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL WERE REVIEWED. DIMENSIONAL ANALYSIS: DIMENSIONAL ANALYSIS PERFORMED ON THE TIP EDGES OF THE RETURNED DEVICE MEASURED THE CORNER TO CORNER TIP DIMENSIONS AND IT FALLS WITHIN THE SPECIFICATION OF PER RELEVANT DRAWINGS. CONCLUSION: WHILE NO ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT THE AGE OF THE DEVICE (APPROXIMATELY 9 YEARS) WITH CONSISTENT USAGE COULD HAVE CONTRIBUTED TO THIS WORN CONDITION WHICH IN TURN CONTRIBUTED TO UNABLE TO ASSEMBLE TO SCREW COMPLAINT CONDITION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. ADDITIONAL NARRATIVE: DATE OF EVENT. ADDITIONAL POSSIBLE SYNTHES LOT NUMBERS: 6330274. ADDITIONAL RELEASE TO WAREHOUSE DATE: (B)(6)2010. 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

    DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FOUR INSERTION SCREWDRIVERS SELF-RETAINING ARE OLD AND BECOMING VERY DULL AND NO LONGER SELF-RETAINING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION SCREWDRIVER. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317503 INSERTION SCREWDRIVER SELF-RETAINING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 324.105 6327282 10705034769332

    Patients

    Seq Age Sex Outcome Treatment
    1