BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL TENSIONING DEVICE

    MDR report key: 6594238 · Received May 26, 2017

    Report

    Report Number
    1719045-2017-10507
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Report Date
    May 3, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10886982198365
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. (THERAPY DATE): UNKNOWN. PART 391.884, SYNTHES LOT P312065: RELEASE TO WAREHOUSE DATE: DECEMBER 20, 2005 AND DECEMBER 22, 2005. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE FOLLOWING COMPLAINT DEVICE(S) WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE CABLE TENSIONER (PART NUMBER: 391.201, LOT NUMBER: P506559, MFG DATE: 22JUN2001) ONE PROVISIONAL TENSIONING DEVICE (PART NUMBER: 391.884, LOT NUMBER: P312065, MFG DATE: 20DEC2005) ONE 1.7MM CABLE (PART NUMBER: 498.806S, LOT NUMBER: P252358, MFG DATE: 15DEC2016). THE PART(S) WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿A 1.7MM CABLE WAS STUCK INSIDE THE TENSIONER AND IT SEEMS TO HAVE COME APART AT THE TIP (UNSCREWED). THE MALFUNCTION OCCURRED DURING A TROCHANTERIC REATTACHMENT DEVICE PROCEDURE ON AN UNKNOWN DATE. A TEN-MINUTE SURGICAL DELAY WAS NOTED. A SPARE CABLE TENSIONER WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. DEVICE 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 A 1.7MM CABLE WAS STUCK INSIDE THE TENSIONER AND IT SEEMS TO HAVE COME APART AT THE TIP (UNSCREWED). THE MALFUNCTION OCCURRED DURING A TROCHANTERIC REATTACHMENT DEVICE PROCEDURE ON AN UNKNOWN DATE. A TEN (10) MINUTE SURGICAL DELAY WAS NOTED. A SPARE CABLE TENSIONER WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 1.7MM CABLE (PART 498.806S, LOT P252358, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    ON 15JUN2017 - UPDATE: PER SYNTHES CUSTOMER QUALITY ENGINEER¿S EVALUATION, IT WAS IDENTIFIED THAT A 1.7MM CABLE WAS FRAYED AND STUCK INSIDE OF A TENSIONER AND IT SEEMS HAVE COME APART AT THE TIP (UNSCREWED). THE MALFUNCTION OCCURRED DURING A TROCHANTERIC REATTACHMENT DEVICE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376052 PROVISIONAL TENSIONING DEVICE MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P312065 10886982198365

    Patients

    Seq Age Sex Outcome Treatment
    1