BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7314812 · Received March 5, 2018

    Report

    Report Number
    2939274-2018-50892
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Report Date
    February 5, 2018
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 314.743, SYNTHES LOT # 9922262 ; SUPPLIER LOT # 9922262 ; RELEASE TO WAREHOUSE DATE: 10MAR2016 ; SUPPLIER: (B)(4): NO NON-CONFORMANCE REPORTS (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 SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE DRIVE SHAFT WAS RECEIVED WITH A PORTION OF THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BROKEN PORTION WAS NOT RECEIVED. THE BREAK IS LOCATED ACROSS APPROXIMATELY HALF OF THE CIRCUMFERENCE AND EXTENDS APPROXIMATELY 4.2MM FROM THE DISTAL EDGE OF THE DRIVE SHAFT. THE HELIX IS INTACT AND SHOWS MINIMAL WEAR. THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS THE RESULT OF FORCE APPLIED TO THE DISTAL END OF THE DRIVE SHAFT RESULTING IN STRESSES BEYOND THE FAILURE LIMIT OF THE SHAFT. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE BREAK ARE UNKNOWN. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT WAS REPORTED. ADDITIONAL PRODUCT CODE: HRX. 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. (B)(6). 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. (B)(4). 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 TIPS OF TWO (2) REAMER / IRRIGATOR / ASPIRATOR (RIA) DRIVE SHAFTS HAVE BROKEN OFF. THIS OCCURRED IN STERILE PROCESSING. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVER SHAFT FOR USE WITH RIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157916 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 9922262 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1