BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 12018548 · Received June 17, 2021

    Report

    Report Number
    2939274-2021-03025
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 18, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188373
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    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. H3, H6: MANUFACTURING LOCATION: BETTLACH. MANUFACTURING DATE: MAY 17, 2002. DUE TO THE AGE OF MORE THAN 10 YEARS OF THE COMPLAINED DEVICE A WEAR OR USE RELATED ROOT CAUSE IS THE MOST LIKELY REASON OF THE COMPLAINED MALFUNCTION. PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE IS FOR COMPLAINTS FOR WHICH A NON-MANUFACTURING RELATED PROBABLE CAUSE HAS BEEN IDENTIFIED NO MANUFACTURING RECORD EVALUATION IS REQUIRED. VISUAL INSPECTION: THE SMALL HEXAGONAL SCRDRIVER HOLDING SLV (P/N: 314.020, LOT NUMBER: 2030733) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE DISTAL TIP WAS TWISTED, THE HANDLE HAD BROKEN, AND THE PROXIMAL SHAFT PIN (INSIDE THE HANDLE) ALSO HAD BROKEN. THE HOLDING SLEEVE COMPONENT WAS ALSO MISSING. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DISTAL TIP WAS TWISTED, THE HANDLE HAD BROKEN, AND THE PROXIMAL SHAFT PIN (INSIDE THE HANDLE) ALSO HAD BROKEN. THE HOLDING SLEEVE COMPONENT WAS ALSO MISSING. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON (B)(6). 2021, THE PATIENT UNDERWENT HARDWARE REMOVAL. THE DOCTOR FIXED THE NONUNION WITH A PLATE AND SCREW CONSTRUCT. AS THE SURGEON WAS TIGHTENING THE LAST SCREW, THE 2.5 HEX SCREWDRIVER BROKE. THE DOCTOR HAD TO REMOVE THE BROKEN PIECES OUT OF THE PATIENT. THE PATIENT HAD A NONUNION AND THE DOCTOR WAS CONCERNED THAT THE BROKEN SCREWDRIVER PIECES COULD CONTAMINATE THE PATIENT AND POTENTIALLY HURT THE HEALING PROCESS. THERE WAS A (15) FIFTEEN-MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913401 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.02 2030733 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNK - PLATES| UNK - SCREWS: LOCKING| UNK - PLATES| UNK - SCREWS: LOCKING