BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 5989786 · Received September 30, 2016

    Report

    Report Number
    3003875359-2016-10524
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Report Date
    September 15, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE APPLICATOR KNOB (PART NUMBER 03.812.004, LOT NUMBER 8062917). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING ON THE APPLICATOR INNER SHAFT THE DISTAL SECTION OF THE FORK SHOWS SIGNS OF FORCE USE DURING HAMMERING. BOTH THE INNER SHAFT AND KNOB SHOW SIGNS OF WEAR AND TEAR. THE COMPLAINT IS CONFIRMED. A COMPLAINT ANALYSIS WAS PERFORMED. THE RESULTING OCCURENCE RATE LIES WITHIN THE ACCEPTABLE RANGE; THE COMPLAINT IS NOT DESIGN RELATED. A VISUAL INSPECTION AND DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NON-CONFORMANCE RECORDS WERE RELEVANT TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. THE MOST PROBABLE ROOT CAUSE IS THAT IMPLEMENTATION OF EXCESSIVE FORCE DURING SURGERY LED TO BREAKAGE OF THE PROXIMAL PIN AND THEREFORE THE FAILURE OF THE INSTRUMENT. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THERE WAS NO PATIENT INVOLVEMENT. MALFUNCTION WAS FOUND ON SEP 15, 2016, BUT IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 26.NOV.2012. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE APPLICATOR INNER SHAFT IS BROKEN ON THE SIDE WHERE THE APPLICATION KNOB IS INSERTED; ADDITIONALLY, THE APPLICATOR KNOB HAS SMALL BROKEN PIECE INSIDE. IT WAS DISCOVERED IN THE LOAN DEPARTMENT; THERE IS NO SURGERY OR PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642033 T-PAL SPACER APPLICATOR KNOB INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF 8062917

    Patients

    Seq Age Sex Outcome Treatment
    1