BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW SELF-DRILLING/4MM

    MDR report key: 6381304 · Received March 6, 2017

    Report

    Report Number
    2520274-2017-10749
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 9, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS UNCONFIRMED. SCREW WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. A 03.503.083 LOT NUMBER U232223 SCREWDRIVER SHAFT WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RELEVANT DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. 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

    (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL CONCOMITANT DEVICE: SCREWDRIVER (PART 03.503.083, LOT U232223, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017 A SELF-DRILLING SCREW'S THREAD BROKE OFF INTRAOPERATIVELY. AS THE SURGEON SCREWED THE SELF-DRILLING SCREW INTO THE PLATE THE SCREW'S THREAD DETACHED IN A LITTLE FILAMENT. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS LEFT BEHIND IN THE PATIENT. BROKEN FRAGMENT WAS REMOVED EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK-UP DEVICE. PATIENT STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: PLATE (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162645 1.85MM TI MATRIX SCREW SELF-DRILLING/4MM BONE, PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY 1)