BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 12752157 · Received November 4, 2021

    Report

    Report Number
    2939274-2021-06496
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Report Date
    October 11, 2021
    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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. INVESTIGATION FLOW: DAMAGE VISUAL INVESTIGATION: THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS (PRODUCT CODE: 319.006, LOT #: 4770603) WAS RECEIVED AT US CQ FOR INVESTIGATION. VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT THE NEEDLE COMPONENT WAS BROKEN OFF AND THE PROTECTION SLEEVE WAS MISSING. THE BROKEN NEEDLE COMPONENT WAS NOT RETURNED FOR INVESTIGATION. THERE WAS SLIGHT DISCOLORATION AND SCRATCHES OBSERVED ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED ON THE DEVICE. DEVICE FAILURE/DEFECT IS IDENTIFIED. COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE AND THE DEFINITIVE FINDING OF A MISSING COMPONENT. DOCUMENT/SPECIFICATION REVIEW: THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE DEPTH GAUGE. 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. 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 #: 319.006 SYNTHES LOT #: 4770603 SUPPLIER LOT #: N/A RELEASE TO WAREHOUSE DATE: 26 MAY 2004 MANUFACTURED BY: SYNTHES BRANDYWINE MRR# 51100 WAS GENERATED DURING PRODUCTION FOR NICK ON HOOK EDGE, RESIDUE ON HOOK BASE, AND NICKS ON PROTECTION SLEEVE ALL DEVICES WERE REWORK, RESIDUE WAS REMOVED FROM THE PART AND NICKS BLENDED TO REMOVE SHARP EDGES. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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 · 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 AN UNKNOWN DATE, SIX (6) DEPTH GAUGES, ONE (1) SPINDLE NUT, ONE (1) WIRE SLEEVE, ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT, AND ONE (1) UNIVERSAL CHUCK WERE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 8 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651236 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 4770603 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 1.6MM WIRE SLEEVE| 7.0 CANN SCR INSTR & IMPL SET GC| DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| HANDLE FOR TORQUE LIMITING ATTACHMENT| SPINDLE NUT| UNIVERSAL CHUCK| 1.6MM WIRE SLEEVE| 7.0 CANN SCR INSTR & IMPL SET GC| DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| HANDLE FOR TORQUE LIMITING ATTACHMENT| SPINDLE NUT| UNIVERSAL CHUCK