BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE DEPTH GAUGE

    MDR report key: 13087372 · Received December 27, 2021

    Report

    Report Number
    3003862213-2021-00009
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    January 1, 2021
    Manufacturer
    UMKIRK SYNTHES GMBH (DE)
    Product Code
    HTJ
    UDI-DI
    07611819894365
    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

    THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE RETURNED DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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 HISTORY LOT: PART: 03.503.036. LOT: L232177. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 16. DEC. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT MATRIXMANDIBLE DEPTH GAUGE WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984361 MATRIXMANDIBLE DEPTH GAUGE GAUGE, DEPTH HTJ UMKIRK SYNTHES GMBH (DE) L232177 07611819894365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown