BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 7351753 · Received March 19, 2018

    Report

    Report Number
    2939274-2018-51114
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 19, 2018
    Report Date
    February 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034770765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE PART # 352.311 SYNTHES LOT # 5051794 SUPPLIER LOT # (B)(4) RELEASE TO WAREHOUSE DATE: 05 AUG 2005 SUPPLIER: (B)(4). MRR # (B)(4) WAS GENERATED ON 02 AUG 2005 FOR A NON-CONFORMANCE OF ETCH ON INNER SHAFT THAT DOES NOT MATCH OUTER SLEEVE. MRB REVIEW OF PRODUCT ETCH AND DRAWING FINDS THE PARTS CONFORMING AS OF 02 AUG 2005. THIS NON-CONFORMANCE FOR ETCH IS NOT RELEVANT TO THE COMPLAINT CONDITION OF BROKEN SUBJECT DEVICE HAS BEEN RECEIVED AND SERVICE & REPAIR EVALUATION. A SERVICE & REPAIR EVALUATION/REVIEW ON (B)(6) 2018: SERVICE EVALUATION COMPLETE, ITEM WILL BE RETURNED TO CUSTOMER. A SERVICE HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE DEVICE IS A LOT/BATCH CONTROLLED ITEM. THE DEVICE WAS DEEMED SERVICEABLE AND RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THE CUSTOMER REPORTED THE SHAFT BROKE OFF IN THE HEAD OF THE REMOVED SCREW. THE REPAIR TECHNICIAN REPORTED THE INNER SHAFT OF THE EXTRACTION TIP WAS BROKEN. TIP BROKEN IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: INNER SHAFT. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON (B)(6) 2018 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 30. THE EVALUATION WAS CONFIRMED. 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

    CORRECTED DATA: DATE OF EVENT: IT WAS PREVIOUSLY REPORTED ON (B)(4) THAT THE EVENT DATE IS (B)(6) 2018. THE CORRECT EVENT DATE IS (B)(6) 2018. IT WAS PREVIOUSLY REPORTED ON THAT THE DATE OF REPORT AND DATE RECEIVED BY MANUFACTURE WAS 2/20/2018. THE CORRECT DATE IS 2/19/2018. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2018 THE REMOVAL SCREWDRIVER SHAFT FOR VECTRA BROKE OFF IN THE HEAD OF THE REMOVED SCREW. THERE IS NO REPORT OF PATIENT HARM OR SURGICAL DELAY. NO ADDITIONAL INFORMATION AT THIS TIME. THERE IS 1 DEVICE IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193694 EXTRACTION SCREWDRIVER SCREW, FIXATION,BONE HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 555359G05 10705034770765

    Patients

    Seq Age Sex Outcome Treatment
    1