BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREPHINE-ATTACHM Ø8.5 F/HOLDER

    MDR report key: 3761560 · Received April 21, 2014

    Report

    Report Number
    9612488-2014-10109
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWK
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION OF THE COMPLAINED TREPHINE ATTACHMENT SHOWS THAT ONE OF THE FRONT TEETH IS INDEED BROKEN OFF. WE CANNOT RELIABLY DETERMINE THE CAUSE WHICH HAS LED TO THIS BREAKAGE (UNFORTUNATELY THE BROKEN PIECES HAVE NOT BEEN RETURNED FOR INVESTIGATION). IT IS LIKELY THOUGH, THAT THE TREPHINE HAD CONTACT WITH METAL (GUIDE WIRE) AND SHATTERED IN BITS. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO THE SPECIFICATION (MANUFACTURED IN AUGUST 2012). THE BROKEN SURFACE ITSELF IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER THE SURGEON PERFORMED A BONE GRAFT HARVESTING IN THE PATIENTS PELVIS; A SET OF THE TEETH OF THE 8.5MM TREPHINE WERE FOUND TO BE MISSING. WITH THE TREPHINE STILL INSIDE OF THE PATIENT; A CLOSER INSPECTION WAS DONE AND THE SURGEON WAS ABLE TO FIND TWO PIECES OF METAL IN THE PELVIC GRAFT SITE THAT BELONGED TO THE TREPHINE. ALL BROKEN TEETH WERE ACCOUNTED FOR. THERE WAS A REPORT OF A FIVE MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240285 TREPHINE-ATTACHM Ø8.5 F/HOLDER TREPHINE HWK SYNTHES BETTLACH 7965969

    Patients

    Seq Age Sex Outcome Treatment
    1