BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/

    MDR report key: 11920936 · Received June 2, 2021

    Report

    Report Number
    8030965-2021-04465
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 20, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART: 03.010.019, LOT: 3792059, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 21 JUNE 2011. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. VISUAL INSPECTION: THE DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ (P/N: 03.010.019, LOT #: 3792059) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT TIP OF THE NEEDLE COMPONENT WAS SLIGHTLY BENT. NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED WITH THE RETURNED DEVICE. THE DEVICE WAS FUNCTIONING AS INTENDED AND THE DEVICE WAS ALSO MEASURING AS INTENDED. THEREFORE, THE REPORTED CONDITION OF MEASURING SHORT WAS NOT CONFIRMED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? NO. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS CANNOT BE PERFORMED DUE TO THE GEOMETRY/DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DOCUMENTS WERE REVIEWED: CURRENT AND MANUFACTURED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO, THE DEVICE WAS MEASURING AND FUNCTIONING AS INTENDED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE RETURNED DEVICE. HOWEVER, THE TIP OF THE NEEDLE WAS OBSERVED TO BE DAMAGED ON THE DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE UNINTENDED FORCES MIGHT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DEPTH GAUGE APPEARED TO MEASURE 4-5MM SHORT OF WHAT WAS ACTUALLY BEING MEASURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818037 DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ GAUGE,DEPTH HTJ SYNTHES GMBH 3792059

    Patients

    Seq Age Sex Outcome Treatment
    1