BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG

    MDR report key: 7862894 · Received September 10, 2018

    Report

    Report Number
    2939274-2018-53691
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034719177
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.632.073, LOT# 7965064. MANUFACTURED BY: (B)(4), RELEASE TO WAREHOUSE DATE: (B)(6) 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION OBSERVED THE DISTAL TIP WAS SLIGHTLY TWISTED. NO NEW ISSUES WERE IDENTIFIED. THE GIVEN COMPLAINT CONDITION AGREES WITH THE RETURNED DEVICE CONDITION AND THEREFORE THE COMPLAINT WAS CONFIRMED. DIMENSIONAL INSPECTION: DIAMETER OF PROXIMAL TO DISTAL TIP: 4.6 +0.03/- 0 MM, MEASURED DIMENSIONS: DISTAL TIP : 4.62 MM; CONFORMING, DEVICE USED: CALIPERS CA215P. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE FORCE IN THE DIRECTION OF SCREW INSERTION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS SYNTHES SALES CONSULTANT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES CANADA REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SPINE (MIS) FUSTION PROCEDURE ON (B)(6) 2018 UTILIZING MATRIX MIS SYSTEM, THE SURGEON NOTICED THAT THE SCREWS WERE POORLY INSERTING INTO THE PEDICLE. ONCE THE CASE WAS COMPLETED, THE SCRUB NURSE NOTICED THAT BOTH STANDARD AND LONG CANNULATED SCREWDRIVER SHAFTS WERE SLIGHTLY STRIPPED AND TWISTED AT THE DISTAL END TIP. THERE WAS NO DELAYED OBTAINED DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO DELAY. PATIENT WAS NOT AFFECTED BY THIS DAMAGE. CONCOMITANT DEVICE REPORTED: LOCKING/SET SCREWS: MATRIX (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LONG CANNULATED STARDRIVE SHAFT FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703466 T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG SCREWDRIVERS HXX WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 7965064 10705034719177

    Patients

    Seq Age Sex Outcome Treatment
    1