BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS

    MDR report key: 19642464 · Received July 1, 2024

    Report

    Report Number
    8030965-2024-08084
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 3, 2024
    Manufacturer
    SYNTHES GMBH
    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

    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. H11 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: PART: 03.111.005 LOT NO:8935213 RELEASE TO WAREHOUSE DATE: 30 JUN, 2014 MANUFACTURING SITE: WERK HAGENDORF A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THE PHOTOS DOESN'T SHOW THE DEVICE BEING BENT/DEFORMED, THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF INCORRECT MEASUREMENT. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE PHOTOGRAPHS ATTACHED DOESN'T DRAW A CONCLUSION ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 ON (B)(6) 2024, DURING POSTOPERATIVE INSPECTION OF THE SET, IT WAS NOTED THAT THE 2 DEPTH GAUGES WERE INOPERABLE. ONE DEPTH GAUGES WAS UNABLE TO SLIDE. THE SECOND DEPTH PROBE WAS EXTREMELY BENT AND THERE WERE CONCERNS FOR INCORRECT MEASUREMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785134 DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS GAUGE, DEPTH HTJ SYNTHES GMBH 8935213 10886982072078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown