BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 6041719 · Received October 19, 2016

    Report

    Report Number
    9612488-2016-10427
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. EXTRACTION SCREW PART NUMBER 309.530, LOT NUMBER 9861596 WAS RECEIVED FOR INVESTIGATION. ALMOST THE ENTIRE LENGTH OF THE THREADED TIP SECTION HAS BROKEN OFF IN AN OBLIQUE WAY. THE BROKEN PART WAS NOT RETURNED. BECAUSE OF THE DAMAGES THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE USED MATERIAL WAS STAINLESS STEEL 1.4112 PER ISO 7153 AS REQUIRED AND THE MEASURED HARNESS WAS WITH 671 - 689 HV10 WITHIN THE SPECIFICATION OF 510-720 HV10. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE MEASURABLE DIMENSIONS WERE WELL DOCUMENTED AND ALL WITHIN THE VALID SPECIFICATIONS. THEREFORE A MANUFACTURING ISSUE CAN BE EXCLUDED. CONSIDERING THE OBLIQUE BREAKAGE AT THE TIP, WE ONLY CAN ASSUME THAT A LATERAL MECHANICAL OVERLOADING, WELL BEYOND ITS CALCULATED DESIGN, IS MOST PROBABLY THE ROOT CAUSE FOR THIS OCCURRENCE. 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. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTING FACILITY STREET ADDRESS AND PHONE NUMBER WERE NOT AVAILABLE FOR REPORTING. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 9861596. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: APR 6, 2016. 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 SUBJECT DEVICE HAS BEEN RECEIVED AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION. 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

    ADDITIONAL INFORMATION WAS PROVIDED; THE REASON FOR THE EXPLANT PROCEDURE IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PLATE, SCREWS, AND DRILL BIT ARE SYNTHES DEVICES AND WHETHER ANY FRAGMENTS WERE RETAINED. PATIENT AND SURGICAL OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING EXPLANT SURGERY ON (B)(6) 2016 OF AN UNKNOWN PLATE AND SCREWS INITIALLY IMPLANTED TO TREAT A PROXIMAL TIBIAL FRACTURE, THE EXTRACTION SCREW INSTRUMENT TIP BROKE LEAVING A TWIST MARK IN THE SCREW HEAD. THE SURGEON ATTEMPTED TO USE A CARBIDE DRILL TO GRIND THE SCREW IN ORDER TO REMOVE IT BUT THIS FAILED. THE SURGEON EXTRACTED THE REMAINING SCREWS THEN WAS ABLE TO PULL OUT THE PLATE STUCK WITH THE BROKEN EXTRACTION SCREW AND WAS ABLE TO EXTRACT THE SCREW. THERE WAS A 45 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692908 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS EXTRACTOR HWB SYNTHES BETTLACH 9861596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention