BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER

    MDR report key: 7230537 · Received January 31, 2018

    Report

    Report Number
    8030965-2018-50745
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Report Date
    January 10, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HXZ
    UDI-DI
    07611819880313
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN THE EVENT OCCURRED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART HAS NOT BEEN RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.607.513, LOT# L143113. MANUFACTURING LOCATION: UMKIRCH, RELEASE TO WAREHOUSE DATE: OCT 12, 2016. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE THE PART IS DAMAGED AS REPORTED. THUS, CONFIRMING THE COMPLAINT DESCRIPTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, 30 PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. NO NON- CONFORMANCE REPORTS WERE MARKED IN THE DHR DURING PRODUCTION. MOREOVER, A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. THE INSTRUMENT HAS BEEN MANUFACTURED, ASSEMBLED AND HARDENED ACCORDING ALL REQUIRED SPECIFICATIONS. DURING INVESTIGATION A HARDNESS TEST GOT PERFORMED, THE TEST IS WITHIN THE SPECIFICATION. FURTHERMORE, ASSEMBLING HAS BEEN PERFORMED ACCORDING THE SPECIFICATION, A 100% VISUAL AND FUNCTIONAL CHECK GOT PERFORMED, ALL RESULTS ACCORDING TO SPECIFICATION. ALL MEASUREMENTS HAVE BEEN DOCUMENTED IN THE INSPECTION SHEET. THE ROOT CAUSE COULD NOT BE DETERMINED AT THE MANUFACTURING SITE. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE MUST ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE OR/AND THAT THAT WEAR AND TEAR FROM OFTEN USE LED TO THIS DAMAGE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN OR DAMAGED INSTRUMENTS TO REPLACE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED DURING THE INTERNAL INVESTIGATION AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE CUTTER BROKE WHILE CUTTING OF A 1.25 CERCLAGE WIRE. THE SURGERY WAS NOT PROLONGED AND THERE WAS NO PATIENT HARM. CONCOMITANT DEVICE: 1X UNKNOWN CERCLAGE WIRE 1.25. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS COMPLAINT IS FOR A CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74558 CABLE CUTTER CUTTER,WIRE HXZ OBERDORF : SYNTHES PRODUKTIONS GMBH L143113 07611819880313

    Patients

    Seq Age Sex Outcome Treatment
    1