BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø2 SELF-TAP L10 TAN

    MDR report key: 3637714 · Received February 20, 2014

    Report

    Report Number
    8030965-2014-00360
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K954385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE BY THE COMPLAINT HANDLING UNIT REVEALED THE SCREW WAS RECEIVED WITH THE HEAD BROKEN OFF. ADDITIONALLY, THE THREADS OF THE SCREW WERE SHEARED. THE SCREW WAS MANUFACTURED IN OCTOBER 2013 ACCORDING TO SPECIFICATIONS. THE INVESTIGATION HAS SHOWN THAT THE HEAD OF THE SCREW BROKE OFF OF THE SCREW. VISUALLY, WE CAN SEE THE THREADS ARE SHEARED AND THE SCREW HEAD IS DETACHED FROM SCREW. THIS IS INDICATIVE OF THE MOST PROBABLE ROOT CAUSE IS EXCESSIVE FORCE AND LOADING. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: DZL, MQN. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE FOLLOWING INCIDENT: ON (B)(6) THE SCREW IN QUESTION WAS USED FOR A THIRD METACARPAL BONE FRACTURE CASE. DURING THE OPERATION, WHEN INSERTING THE SCREW OVER THE PLATE, IT BROKE OFF JUST BELOW THE HEAD PART. NO BROKEN PART WAS LEFT IN THE PATIENT. A 60-MINUTE PROLONGATION OF THE SURGERY WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107366 CORTSCR Ø2 SELF-TAP L10 TAN JEY SYNTHES GMBH 8684425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention