BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL TENSIONING DEVICE

    MDR report key: 10566797 · Received September 22, 2020

    Report

    Report Number
    1833824-2020-00071
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    RTI SURGICAL
    Product Code
    LXH
    UDI-DI
    07611819719859
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D10: DEVICE RETURNED 9/10/2020. INVESTIGATION SUMMARY: BACKGROUND: DURING A DEMONSTRATION OF THE CABLE SYSTEM IN QEH, THE 1.7 CABLE LOCK, AND 2 PCS OF TENSION HOLDER CANNOT HOLD THE 1.7 CABLE PROPERLY CONCOMITANT DEVICE REPORTED: UNKNOWN 1.7MM CABLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. NOTE: THE COMPLAINT DEVICE WAS EVALUATED AND INVESTIGATED AT THE SUPPLIER, RTI (PIONEER SURGICAL). "(B)(4) INVESTIGATION REPORT 12OCT2020 (1)" WITHIN PI FOR THE INVESTIGATION REPORT. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE PROVISIONAL TENSIONING DEVICE (PART #: 391.884 AND LOT #: P313918) WAS INSPECTED BY RTI. THE VISUAL INSPECTION DID NOT REVEAL ANY NON-CONFORMITY. FUNCTIONAL TEST: DURING FUNCTIONAL INSPECTION, THE CAM LEVER WAS FOUND DIFFICULT TO LOCK ONTO 1.7MM CABLE UNTIL LUBRICATED. ONCE LUBRICATED THE REAR BIT PASSED FUNCTIONAL PER THE RTI WORK INSTRUCTION WI-ENG-006 WITH A TENSIONING READING OF 40.8K AND ZERO CABLE FRAYS. COMPLIANT COULD NOT BE REPLICATED AFTER THE DEVICE WAS LUBRICATED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED BECAUSE THE COMPLAINT WAS NOT ABLE TO REPLICATE AND THE DEVICE PASSED FUNCTIONAL TESTING. DOCUMENT/SPECIFICATION REVIEW: 391_884.DRW REV D (CURRENT) AND REV C (MANUFACTURED) WERE REVIEWED. A DHR REVIEW WAS CONDUCTED BY THE SUPPLIER AND IT REVEALED THAT THE DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO SHIPPING. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED FOR THE PROVISIONAL TENSIONING DEVICE (P/N: 391.884, LOT NUMBER: P313918) AS THE DEVICE NEEDED TO BE LUBRICATE TO PERFORM AS INTENDED. ONCE THE DEVICE WAS LUBRICATED IT PASSED FUNCTIONAL TESTING. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION BUT THIS CONDITION COULD LIKELY DUE TO POOR MAINTENANCE OF THE DEVICE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H6: DEVICE HISTORY LOT: PART # 391.884; SYNTHES LOT # P313918; SUPPLIER LOT # P313918; RELEASE TO WAREHOUSE DATE: 11 JUL 2018; SUPPLIER: (B)(4); NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY 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. H11: LOT NUMBER PROVIDED FOR REPORTING. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS COMPANY REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A DEMONSTRATION OF THE CABLE SYSTEM ON (B)(6) 2020, THE 1.7 MM CABLE LOCK, AND 2 PIECES OF TENSION HOLDER CANNOT HOLD THE CABLE PROPERLY. NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN 1.7MM CABLE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029443 PROVISIONAL TENSIONING DEVICE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH RTI SURGICAL P313918 07611819719859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - CABLE/WIRE.| UNK - CABLE/WIRE