BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS

    MDR report key: 13060980 · Received December 22, 2021

    Report

    Report Number
    2939274-2021-07192
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982072078
    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 SYNTHES EMPLOYEE. (B)(6) 2021. PART # 03.111.005 LOT # 8935213 RELEASE TO WAREHOUSE DATE: (B)(6), 2014 MANUFACTURER: HAGENDORF NO NCR'S WERE GENERATED DURING PRODUCTION. PART: 03.111.005 LOT: 3740500 MANUFACTURING SITE: HAGENDORF SUPPLIER: N/A RELEASE TO WAREHOUSE DATE: AUGUST 25, 2011 EXPIRATION DATE: N/A A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE COMPLAINT DEVICE DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS (PRODUCT CODE: 03.111.005, LOT NUMBER: 8935213) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. THE MEASURING NEEDLE PART OF THE DEPTH GAUGE WAS BENT. NO OTHER ISSUES WERE IDENTIFIED. DEVICE/DEFECT IDENTIFIED: YES DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISIONS OF DRAWING WERE REVIEWED. DEPTH GAUGE FOR SCREWS 2.0/2.4/2.7 DIMENSIONAL INSPECTION: DIAMETER OF THE MEASURING TIP: MEASURED DIMENSION, CONFORMING MEASURING DEVICE USED: CALIPER COMPLAINT CONFIRMED: COMPLAINT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. CONCLUSION: THE NEEDLE OF THE DEPTH GAUGE WAS BENT, HENCE THE COMPLAINT WAS CONFIRMED. 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 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 2.0MM/2.4MM AND 2.7MM SCREWS. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963337 DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.111.005 8935213 10886982072078

    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 LCKNG SCRS TO 100| 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| UNK - SCREWDRIVERS