BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI HEADLESS COMPRESSION SCREW 18MM-STERILE

    MDR report key: 5578529 · Received April 14, 2016

    Report

    Report Number
    3000270450-2016-10092
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK090949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE NON-STERILE VERSION OF THE PART: NON-STERILE PART 04.230.118, LOT 9074414: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JULY 15, 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION (B)(6). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY ON 04.230.118S / LOT 9080537, NO DEVIATION FOUND. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 30TH JULY 2014, EXPIRY DATE: 1ST JULY 2024. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE THE SURGEON WAS INSERTING THE REPORTED SCREW AND PUTTING COMPRESSION, IT STARTED IDLING. THE SURGEON THEN FOUND THAT THE SCREW WAS BROKEN UNDER THE HEAD AND ONLY THE HEAD PART WAS ATTACHED TO THE COMPRESSION SLEEVE. AS THE SHAFT PART REMAINED IN THE PATIENT'S BONE, HE DECIDED TO LEAVE IT AND INSERTED A SPARE SCREW WITHOUT ANY PROBLEM. THERE WAS A 15-MINUTES SURGICAL DELAY; HOWEVER, THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232781 1.5MM TI HEADLESS COMPRESSION SCREW 18MM-STERILE SCREW, FIXATION, BONE HWC SYNTHES SELZACH 9080537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention