BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 7131615 · Received December 19, 2017

    Report

    Report Number
    2939274-2017-50379
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    November 21, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW: PART NUMBER: 314.743 SYNTHES LOT NUMBER: 5480910 SUPPLIER LOT NUMBER: 14657-01, RELEASE TO WAREHOUSE DATE: 14 DEC 2006, SUPPLIER: CRITERION TOOL & DIE, INC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE RETURNED RIA DRIVE SHAFT (314.743, 14657-01) IS INCLUDED IN THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM USED FOR INTRAMEDULLARY REAMING AND BONE HARVESTING. THE RETURNED SHAFT WAS FOUND TO HAVE ITS DISTAL TIP BROKEN OFF, WHICH CONFIRMED ITS COMPLAINT CONDITION AND MADE ITS REPLICATION INAPPLICABLE. THE RETURNED RIA DRIVE SHAFT (314.743, 14657-01) WAS MANUFACTURED ON 14DEC06 AND DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO MRRS, NCRS, OR ACTIONS RELATED TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION OF THE RETURNED PART(S). REVIEW OF DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT(S), WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE MATERIAL, MATERIAL PROPERTIES, AND HARDNESS OF THE RETURNED PART(S) WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE AND BASED ON REVIEW OF THE ASSOCIATED/AVAILABLE DHR(S) AND BASED ON THE DETAILS OF THE COMPLAINT AND INVESTIGATION OF THE RETURNED PART(S), ADDITIONAL MATERIAL/HARDNESS TESTING IS NOT REQUIRED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES 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. DUE TO POST-MARKET DAMAGE OF THE DISTAL TIP OF THE SHAFT, NO RELEVANT FEATURES COULD BE EFFECTIVELY MEASURED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION. CONSIDERING THE POTENTIALLY CHALLENGING CIRCUMSTANCES EXPERIENCED DURING REAMING/ASPIRATION/IRRIGATION IT IS POSSIBLE THAT THE CUMULATIVE EFFECT OF EXPOSURE TO EXTREME CONDITIONS DURING ITS OVER 10 YEAR LIFESPAN CAUSED THE TIP OF THE DRIVE SHAFT TO BECOME VULNERABLE TO BREAKAGE. ALSO, IF REAMING WAS PERFORMED ON UNUSUALLY DENSE/HARD BONE THE CUMULATIVE EFFECT OF THE SUBSEQUENT FORCES EXPERIENCED BY THE TIP OF THE DRIVE SHAFT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IT WAS REPORTED THAT THE SHAFT WAS FOUND TO BE BROKEN AFTER STERILIZATION, BUT NOT DURING OR AFTER THE PROCEDURE IT WAS LAST USED IN. BASED ON THE AVAILABLE INFO IT IS MOST LIKELY THAT THE SHAFT EITHER NOT BEING STORED PROPERLY DURING STERILIZATION, OR BEING HANDLED IN A ROUGH MANNER DURING PROCESSING, CONTRIBUTED TO THE BREAKAGE OF ITS DISTAL TIP. DATE RETURNED TO MANUFACTURER. 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

    NO PATIENT INVOLVEMENT WAS REPORTED. DATE OF DEVICE BREAKAGE IS NOT KNOWN. ADDITIONAL PRODUCT CODE: HRX. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 THE TIP OF THE REAMER-IRRIGATOR-ASPIRATOR (RIA) DRIVE SHAFT WAS BROKEN OFF. THE SHAFT HAD BEEN USED DURING A CASE ON (B)(6) 2017 WITH NO NOTED ISSUES DURING OR AFTER THE CASE. THE DEVICE WENT THROUGH STERILE PROCESSING ON (B)(6) OR (B)(6) 2017. THE SHAFT WAS DISCOVERED BROKEN ON (B)(6) 2017. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907144 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 314.743 14657-01 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1