BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 28MM

    MDR report key: 3880920 · Received June 18, 2014

    Report

    Report Number
    9612488-2014-10231
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE MICROSCOPIC INVESTIGATIONS OF THE COMPLAINED LOCKING SCREW MANUFACTURED IN NOVEMBER 2013 SHOWS THAT THE THREADS ON THE LOCKING HEAD AS WELL AS THE THREADS ON THE SCREW SHAFT WERE DAMAGED DURING USE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE ANODIZED GREEN COLOR WAS ABRADED ALMOST ON THE ENTIRE LENGTH. THE FLANKS ARE ROUNDED AND WORN. THE REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CONDITION OF THE RETURNED DEVICE INDICATES THAT THE SCREW CAME IN CONTACT WITH THE PLATE DURING INSERTION OR EXTRACTION WHILE USE. NO PRODUCT RELATED CONDITION WAS 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

    DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 WHILE INSERTING THE 3.5 LOCKING SCREWS TO PHILOS, THE PAINT OF THE SCREW WAS STRIPPED AND LEFT A COIL. THE SURGEON DID IRRIGATION FOR AN ADDITIONAL THIRTY MINUTES. NO PATIENT HARM WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357076 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM APPLIANCE, FIXATION, NAIL KTT SYNTHES BETTLACH 8729112

    Patients

    Seq Age Sex Outcome Treatment
    1