BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 3965034 · Received July 29, 2014

    Report

    Report Number
    9680938-2014-10042
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 #T943216 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE TEETH DO NOT ENGAGE. THE REPAIR TECHNICIAN REPORTED THE RATCHET WAS WORN. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING FOR FURTHER INVESTIGATION. A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE SEEMS TO BE IN GOOD CONDITION. THE TEETH DO NOT ENGAGE WHEN THE FORCEPS GETS CLOSED. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. HOWEVER WE CANNOT CONCLUDE EXACTLY WHY THE RATCHET DOES NOT ENGAGE. 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 TEETH FOR THE REDUCTION FORCEPS WILL NOT ENGAGE. THIS WAS FOUND AFTER WASHING; THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440834 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD SYNTHES TUTTLINGEN T943216

    Patients

    Seq Age Sex Outcome Treatment
    1