BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 11038393 · Received December 18, 2020

    Report

    Report Number
    2939274-2020-05647
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    November 24, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H4, H6: PART: 319.006, SYNTHES LOT: 7771006, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: AUGUST 20, 2014, EXPIRATION DATE: N/A, MANUFACTURED BY (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE NEEDLE COMPONENT OF THE DEVICE GOT BROKEN AT PROXIMAL END. IT IS ALSO OBSERVED THAT THE PROTECTION SLEEVE COMPONENT WAS ALSO MISSING FROM THE ASSEMBLY. REST OF THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THUS, THE COMPLAINT IS BEING CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ DUE TO POST MANUFACTURING DAMAGE. DOCUMENTATION/ SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: DEPTH GAUGE FOR 2.0/ 2.4MM SCREWS PROTECTION SLEEVE NEEDLE NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS AS IT IS OBSERVED THAT THE NEEDLE COMPONENT IS BROKEN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PROBLEM, BUT THERE IS HIGH POSSIBILITY THAT THE NEEDLE COMPONENT MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. PROTECTION SLEEVE MIGHT HAVE GOT MISPLACED DURING STERILIZATION. DURING THE INVESTIGATION, NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    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 ON AN UNKNOWN DATE, THE DEPTH GAUGES FOR 2.0MM AND 2.4MM SCREWS WERE FOUND MISSING THE TIP. THE SPS MANAGER HANDED THE INSTRUMENT AFTER DECONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506224 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 7771006 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS