BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP

    MDR report key: 11867173 · Received May 21, 2021

    Report

    Report Number
    8030965-2021-04155
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    UDI-DI
    07611819900479
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HXQ. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE APPLIC-FORCEPS F/RAPIDSORB CRANIAL CLAMP (P/N: 329.317, LOT #: A7PA46) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE DISTAL PORTION OF THE PUSH ARM COMPONENT WAS OBSERVED TO BE SLIGHTLY BROKEN AND RUST WAS OBSERVED ON THE UPPER JAW COMPONENT. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. THE OVERALL FUNCTIONAL TEST WAS NOT PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. HOWEVER, THE PUSH ARM WAS OBSERVED TO BE BROKEN WHICH COULD HAVE CAUSED THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT CONDITION WAS CONFIRMED FOR THE (B)(6) (P/N: 02.118.401, LOT # H771082). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 329.317. LOT: A7PA46 . MANUFACTURING SITE: (B)(4). SUPPLIER: CHR. DIENER GMBH & CO. KG. RELEASE TO WAREHOUSE DATE: 23. NOV. 2006. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT WAS DELIVERED TO STERILIZATION UNIT WITH A NOTE THAT IT DOES WORK. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE DISTAL PORTION OF THE PUSH ARM COMPONENT WAS SLIGHTLY BROKEN AND RUST WAS OBSERVED ON THE UPPER JAW COMPONENT. THIS REPORT IS FOR ONE (1) APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763739 APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP CUTTER, WIRE HXZ SYNTHES GMBH A7PA46 07611819900479

    Patients

    Seq Age Sex Outcome Treatment
    1