BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREPHINE ATTACHMENT 8.5MM DIAMETER

    MDR report key: 3827965 · Received May 22, 2014

    Report

    Report Number
    9612488-2014-10191
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWK
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION OF THE COMPLAINED TREPHINE ATTACHMENT SHOWS THAT INDEED THREE OF THE FRONT TEETH ARE COMPLETELY BROKEN OFF. WE CANNOT RELIABLY DETERMINE THE CAUSE WHICH HAS LED TO THIS BREAKAGE. IT IS LIKELY THAT THE TREPHINE HAD CONTACT WITH METAL (GUIDE WIRE) AND SHATTERED IN BITS. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO THE SPECIFICATION. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. NO NCRS WERE GENERATED DURING PRODUCTION. 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. 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 DURING HARVESTING OF BONE GRAFT FROM THE ILIAC CREST THE SURGEON NOTICED THREE TEETH OF THE TREPHINE FROM THE SYNTHES BONE GRAFT HARVESTING SET WERE BROKEN OFF AND MISSING. THE SURGEON FOUND ONE IN THE CAVITY AND ONE IN THE HARVESTED GRAFT. THE THIRD TOOTH WAS NOT FOUND. AN X-RAY WAS TAKEN OF THE ILIAC CREST AND NO EVIDENCE OF THE MISSING TREPHINE TOOTH WAS WITNESSED. THE NO REPORTED HARM TO THE PATIENT. THERE WAS A TEN MINUTE DELAY IN THEATRE TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305529 TREPHINE ATTACHMENT 8.5MM DIAMETER TREPHINE HWK SYNTHES BETTLACH 7965969

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention