BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR LCKNG SCRS TO 100

    MDR report key: 13011989 · Received December 15, 2021

    Report

    Report Number
    2939274-2021-07102
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982067449
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: REPORTER IS A J&J EMPLOYEE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: VISUAL INSPECTION: THE COMPLAINT DEVICE DEPTH GAUGE FOR LCKNG SCRS TO 100 (PRODUCT CODE: 03.010.072, LOT NUMBER: L832726) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. DURING VISUAL INSPECTION, THE DEPTH GAUGE NEEDLE WAS BENT AND DEFORMED. THE GAUGE WAS MISSING THE BODY COVER AND THE DOWEL PIN ON THE SLIDER. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF THE DRAWINGS WERE REVIEWED. LOCKING SCREW MEASURING DEVICE FOR 188MM SLEEVE, 03_010_072, REV H (CURRENT) AND REV F(MANUFACTURED) BODY LOCKING SCREW MEASURING DEVICE, 03_010_071_1 REV D (CURRENT) AND REV C (MANUFACTURED) SLIDER ASSEMBLY, 03_010_072_2, REV H (CURRENT) AND REV F(MANUFACTURED) DOWEL PIN, ES0003-19 REV F (CURRENT AND MANUFACTURED) HOOK SLIDER ASSEMBLY, 03_010_072_2_2 REV D (CURRENT AND MANUFACTURED) SE_022863 REV AF DIMENSIONAL INSPECTION: ACCORDING TO 03_010_072_2_2 REV D, DIAMETER: 1.1 MM ± 0.1 MM (SPECIFIED DIMENSION) DIAMETER: 1.06 MM (MEASURED DIMENSION, CONFORMING) CONCLUSION: THE DEPTH GAUGE NEEDLE WAS BENT AT THE HOOK, MISSING THE COVER AND THE DOWEL PIN. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED DURING INVESTIGATION. 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 - NO NCRS WERE GENERATED DURING PRODUCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER INSPECTION OF THE BACK UP INSTRUMENTS, THESE WERE SET ASIDE FOR COMPLAINTS. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LCKNG SCRS TO 100. THIS IS REPORT 2 OF 2 FOR COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910555 DEPTH GAUGE FOR LCKNG SCRS TO 100 GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.072 L832726 10886982067449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 3.5 VA LCKNG SCR SLF-TPNG/SD/85| BENDING IRON FOR 2.7MM & 3.5MM PLATES| CANN CONNECTING SCREW FOR STD INSRT H&LE| CANNULATED 2.5MM HEXAGONAL SCREWDRIVER| DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS| DEPTH GAUGE FOR LCKNG SCRS TO 100| EXTRACTION SCR FOR TI FEM & TIB NAIL| GD BLK 2.7/3.5 VA ANTLAT DSTL TIB PL/RT| SCRDRIVERSHAFT-HEX-LRG Ø3.5 L165 F/QC| SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE| SDDRIVE SCREWDRIVER SHAFT T8 105MM| SHARP HOOK| SMALL HEXAGONAL SCREWDRIVER SHAFT