BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER-CRUCIF-CANN Ø3

    MDR report key: 2994121 · Received March 8, 2013

    Report

    Report Number
    3003787298-2013-00010
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE TIP IS INDEED BROKEN OFF. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. WE THEREFORE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE HAVE TO ASSUME, THAT EXCEEDING APPLIED MECHANICAL FORCES DURING REMOVAL CAUSED THIS BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SCREW REMOVAL ON AN UNKNOWN PROCEDURE ON (B)(6) 2013. THE CRUCIATE TIP OF THE SCREWDRIVER BROKE. NO FURTHER INFORMATION AVAILABLE THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99322 SCRDRIVER-CRUCIF-CANN Ø3 HXX SYNTHES JENNERSVILLE 6650821

    Patients

    Seq Age Sex Outcome Treatment
    1