BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5191734 · Received October 30, 2015

    Report

    Report Number
    2520274-2015-16946
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: WE HAVE RECEIVED ARTICLE 04.503.104.04S FOR INVESTIGATION. OUR PROVIDED VISUAL INSPECTION HAS SHOWN THAT THE TIP IS SLIGHT BLUNT AND NICKS WERE DETECTED ON THE THREAD FLANKS. THE RECESS DOES HAVE SOME SCRATCHES BUT IS OTHERWISE IN WORKING ORDER. THE ROOT CAUSE CANNOT BE DEFINED EXACTLY. IT IS LIKELY THAT THE SCREW WAS USED AND BY INSERTION GOT DAMAGED. DEVICE IS WORN FROM NORMAL USE AND SERVICING, THERE IS NO INDICATION FOR MATERIAL OR DESIGN RELATED ISSUE WAS FOUND. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. THE REVIEW OF THE DHR SHOWED NO MANUFACTURING RELATED PROBLEM WITH THIS ARTICLE AND LOT NUMBER. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE WAS NOT IMPLANTED OR EXPLANTED DURING THE PROCEDURE. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE US. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 A SURGEON DISCOVERED A SCREW WITH A NICKED TIP DURING A SURGICAL PROCEDURE ON (B)(6) 2015. THE SCREW WAS RENDERED NON-USABLE. THE PACK CONTAINED THREE (3) OTHER STERILE SCREWS THAT HAD NO REPORTED PROBLEM IN THE TARGET REGION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721930 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1