BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7837605 · Received August 31, 2018

    Report

    Report Number
    2939274-2018-53556
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Report Date
    July 3, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. ADDITIONAL DEVICE PRODUCT CODE: HRX. SUPPLIER LOT NUMBER REPORTED AS 13928-01. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR ITEM: 314.743, LOT: 5020042: REC'D QTY: 120, MFG DATE: 02 JUN 2005, MANUFACTURER: CRITERION TOOL & DIE, INC WITH INSPECTION AND PACKAGING IN MONUMENT: PRODUCT WAS INSPECTED AND PASSED PER CERTIFICATES OF CONFORMANCE RECEIVED FROM CRITERION TOOL & DIE, INC, INDICATING THAT PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS LOT. MATERIAL REVIEW WAS NOT PERFORMED AS THE DEVICE IS SUPPLIER PART AND THE SUB COMPONENTS ARE NOT LOT TRACKED. 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 THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. THE FOLLOWING INVESTIGATIONS WERE PERFORMED: BROKEN: DEVICE CONDITION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) ON THE RETURNED DRIVE SHAFT OBSERVED A PORTION OF THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BROKEN PORTION WAS NOT RECEIVED. THE HELIX ADJACENT TO THE BREAK IS INTACT. FURTHERMORE, THE PROXIMAL CONNECTING THREADED PORTIONS SHOWS WORN SURFACES. THE RECEIVED DEVICE IS CONSISTENT WITH THE GIVEN COMPLAINT CONDITION AND THEREFORE THE COMPLAINT CONDITION WAS CONFIRMED. DIMENSIONAL ANALYSIS AND DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION) WERE REVIEWED, AND NO DESIGN ISSUES WERE IDENTIFIED. DIMENSIONAL ANALYSIS PERFORMED AT THE TIP OUTER DIAMETER MEASURED AND IS WITHIN THE SPECIFICATION OF PER RELEVANT DRAWING. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THE PRODUCT WAS INSPECTED AND PASSED PER (B)(4), REV D. CERTIFICATES OF CONFORMANCE RECEIVED FROM CRITERION TOOL & DIE, INC, INDICATING THAT PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS LOT. MATERIAL REVIEW WAS NOT ABLE TO BE PERFORMED AS THE SUB COMPONENTS ARE NOT LOT TRACKED. HOWEVER BASED OFF THE DEVICE AGE (OVER 13 YEARS) THERE IS NO INDICATION THAT THE GIVEN MATERIAL HAS CONTRIBUTED TO COMPLAINT CONDITION. THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION CONCLUSION: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PROVIDED INFORMATION. HOWEVER, IT IS LIKELY THAT ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE DURING USAGE/HANDLING COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION WAS CONFIRMED. HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING A ROUTINE INSPECTION OF THE FIELD EQUIPMENT, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) DRIVE SHAFT WAS DISCOVERED TO HAVE A DAMAGE AT THE TIP OF THE SHAFT, THE TIP OF THE CANNULATED HEXAGONAL SCREWDRIVER WAS ALSO FOUND DAMAGED. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT A PORTION OF THE DISTAL TIP OF THE SHAFT, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680061 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 5020042 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1