BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES

    MDR report key: 4240358 · Received November 10, 2014

    Report

    Report Number
    9680938-2014-10080
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE WAS BROKEN. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT ONE PLATE CUTTER FOR 1.0MM-2.0MM PLATES (PART# 391.98, LOT# T102931, MFG JUL2014) WAS RETURNED WITH THE COMPLAINT THAT ¿THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THE PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM AND 2.0MM PLATE BROKE.¿ UPON RECEIPT OF THE DEVICE IT WAS SEEN THAT BOTH THE LOWER AND UPPER CUTTING EDGES ARE MISSING A 5MM ¿ 8MM SECTION OF MATERIAL, CONFIRMING THIS COMPLAINT. THE REMAINDER OF THE PLATE CUTTERS IS IN GOOD CONDITION WITH NO OTHER SIGNS OF DAMAGE. IT IS PLAUSIBLE THAT THESE PLATE CUTTER BLADES BROKE DUE TO USE WITH MATERIAL OUTSIDE THE RANGE OF USE, HOWEVER IT IS NOT KNOWN WHAT ULTIMATELY CAUSED THIS FAILURE GIVEN THE LACK OF INFORMATION. THE DRAWINGS FOR THIS DEVICE WERE REVIEWED (391_98 REV E AND 391_98 REV F). THE DEVICE WAS FOUND TO CONFORM TO THE DESIGN DIMENSIONALLY MINUS THE BROKEN ASPECT OF THE BLADES. THIS COMPLAINT IS CONFIRMED. IT IS NOT KNOWN WHAT ULTIMATELY CAUSED THIS COMPLAINT CONDITION, HOWEVER, GIVEN THE HIGH OCCURRENCE RATE AN ADDITIONAL TASK HAS BEEN LAUNCHED. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: LOT T102931: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    IT WAS REPORTED THAT THE PLATE CUTTER BROKE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722399 PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ SYNTHES TUTTLINGEN T102931

    Patients

    Seq Age Sex Outcome Treatment
    1