BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

    MDR report key: 5311186 · Received December 18, 2015

    Report

    Report Number
    3009450884-2015-10094
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 1, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PPREADMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE AND 510K - K083213, HRS. NOT EXPLANTED. (B)(6). DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 24.JULY 2012, EXPIRY DATE: 01.JULY 2022, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 206.045 / 7971416 WAS MANUFACTURED IN (B)(4), PART NUMBER 206.045, LOT# 7971416, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 27.JUNE 2012, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING OPEN REDUCTION INTERNAL FIXATION ANKLE, SCREW WAS INTRODUCED AS THE SCREW WAS NEARLY FULLY ENGAGED IN BONE, THE HEAD OF THE SCREW SNAPPED OFF. WHEN TRYING TO REMOVE THE BROKEN SHAFT OF THE SCREW, ANOTHER BREAK IN THE SCREW OCCURED, LEAVING PART OF THE SHAFT OF THE SCREW BROKEN AND IN PATIENT. PATIENT INVOLVED. E-MAIL DATED (B)(6) 2015 THAT THE SCREW HEAD AND THE PART OF THE SHAFT WERE REMOVED, HOWEVER A SMALL PIECE WAS LEFT INTO THE PATIENT'S BODY. IT WILL NOT BE REMOVED, SURGEON HAD DECIDED APPARENTLY THE RISKS OF PROLONGING ANESTHETIC AND RETRIEVAL WERE FAR LESS THAN LEAVING IN. THE BITS REMOVED WERE DISPOSED OF. ONLY SUPPLIED WITH THE ITEM NUMBER AND LOT NUMBER. SURGICAL DELAY WAS NOT MORE THAN 5 MINUTES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836454 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 7998481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention