BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 5038206 · Received August 28, 2015

    Report

    Report Number
    9612488-2015-10438
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. THE REPORTED PART NUMBER, 04.503.104.04S, DID NOT CORRESPOND WITH THE REPORTED LOT NUMBER AND IS NOT IS NOT DISTRIBUTED IN THE UNITED STATES. THIS DEVICE IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW REVEALED THAT THE REPORTED LOT NUMBER DID NOT MATCH THE REPORTED PART NUMBER AND IS ASSOCIATED WITH PART NUMBER 04.503.104.01S, TI MATRIXNEURO SCREW SELF-DRILLING 4MM, DEVICE PRODUCT CODE-JEY, COMMON NAME-BONE PLATE, 510(K) K042365. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 3TH JULY 2013, EXPIRY DATE:1ST JUNE 2023. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE SUBJECT DEVICE WAS REPORTEDLY DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREW WAS UNABLE TO BE INSERTED IN THE BONE WHEN THE SURGEON TRIED TO INSERT THE SCREW DURING SURGERY. WHEN THE SURGEON CHECKED THE SCREW IT WAS DISCOVERED THAT THE TIP OF THE SCREW WAS BROKEN. THERE WAS NO REPORTED SURGICAL DELAY OR PATIENT HARM DUE TO THE REPORTED ISSUE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571858 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C BONE PLATE JEY SYNTHES BETTLACH 8496077

    Patients

    Seq Age Sex Outcome Treatment
    1