BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BLADE 10MM

    MDR report key: 5060846 · Received September 8, 2015

    Report

    Report Number
    9680938-2015-10087
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION EVALUATION: THE CHISEL IS BROKEN IN HALF. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A HARDNESS TEST WAS PERFORMED AND FOUND TO BE CONFORMING AT 59.9 HRC. NO MANUFACTURING ISSUE WAS FOUND DURING THE INVESTIGATION. THE LIKELY CAUSE OF EVENT WAS TOO MUCH APPLIED FORCE. DEVICE 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

    ADDITIONAL NARRATIVE: 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 IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART HAS NOT BEEN RECEIVED FOR REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING DATE: JUNE 9, 2015. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL, WHICH WAS DELIVERED AS LOT U72188, IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING 58.6 HRC AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO (2) CHISEL BLADES BROKE DURING A SURGICAL PROCEDURE ON (B)(6) 2015. THERE WAS NO REPORTED TIME DELAY AS THE ISSUE WAS RESOLVED WITH THE UTILIZATION OF A LIKE PRODUCT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593097 CHISEL BLADE 10MM CHISEL, SURGICAL INSTRUMENT FZO SYNTHES TUTTLINGEN T122455

    Patients

    Seq Age Sex Outcome Treatment
    1