BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER

    MDR report key: 8292673 · Received January 31, 2019

    Report

    Report Number
    8030965-2019-60522
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Report Date
    January 14, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXZ
    UDI-DI
    07611819880313
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: UPON RECEIPT IT WAS NOTED THAT THE TIP OF THE INSTRUMENT IS BROKEN. VISUAL INSPECTION: ONE CORNER OF THE FRONT CUTTER JAW IS BROKEN OFF; THE BROKEN OFF PART WAS NOT RETURNED FOR INVESTIGATION. MATERIAL /HARDNESS REVIEW: THIS INSTRUMENT IS MADE OF STAINLESS ACCORDING TO THE RELEVANT TEST INSTRUCTION THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATION. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS ONE CORNER OF THE CUTTING JAW IS BROKEN OFF. THIS PRODUCTION LOT (L935233) WAS MANUFACTURED IN JULY 2018 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE HARDNESS WAS MEASURED FOR MATERIAL AT THE TIME OF MANUFACTURING AND WAS FOUND TO COMPLY WITH SPECIFICATION . THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS AND IT CAN BE ASSUMED THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. PLEASE NOTE: THE STOPPER ON THE SIDE OF THE CUTTER IS USUALLY NOT EXPOSED TO ANY FORCE DURING THE CUTTING PROCEDURE AS THERE IS A CLEAR GAP BETWEEN THE STOPPER AND THE CORNER IN CLOSED POSITION. IT IS LIKELY THAT AN OBSTACLE OF ANY KIND WAS BETWEEN THE STOPPER AND THE CORNER DURING THE CUTTING PROCEDURE CAUSING A MECHANICAL OVERLOAD. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART: 03.607.513, LOT: L935233, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 07/11/2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ACCORDING TO THE RELEVANT TEST INSTRUCTION THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATION REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON AN UNKNOWN DATE, THE TIP OF THE FRONT CUTTER BROKE AFTER TWO (2) MONTHS. IT WAS UNKNOWN WHEN WAS THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85303 CABLE CUTTER CUTTER,WIRE HXZ OBERDORF SYNTHES PRODUKTIONS GMBH L935233 07611819880313

    Patients

    Seq Age Sex Outcome Treatment
    1