BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 11MM

    MDR report key: 4351639 · Received December 22, 2014

    Report

    Report Number
    2520274-2014-15522
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW COULD NOT BE CONDUCTED DUE THE INSUFFICIENT INFORMATION¿S. INVESTIGATION WAS NOT POSSIBLE DUE THE MISSING MATERIAL. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 2.7MM VA LOCKING SCREWS. PARTIAL CATALOG NUMBER REPORTED AS, 0.211.0XX, WAS REPORTED IN THE INITIAL REPORT AS NUMBER, 02.211.011, IN ERROR. WITHOUT THE LAST TWO DIGITS OF THE PART NUMBER THE CORRESPONDING 510(K) AND ADDITIONAL PRODUCT CODES CANNOT BE DETERMINED. THE PREVIOUSLY REPORTED 510(K) NUMBER K100776 AND PRODUCT CODE HRS ARE ASSOCIATED WITH SOME SCREWS FROM THIS PRODUCT FAMILY. 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 OF MULTIPLE 2.7MM VA LOCKING SCREWS BREAKING AT TOP OF SHAFT BELOW HEAD. THIS OCCURRED WHILE IN SITU. SURGERY TYPE: REMOVAL VA FOOT PLATE - 1ST MTP FUSION PLATE. NO PROBLEMS REPORTED PATIENT RELATED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841267 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 11MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1