BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH CAP INSERTER

    MDR report key: 4140615 · Received October 3, 2014

    Report

    Report Number
    1526439-2014-11956
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONARCH CAP INSERTER WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO EMERGING TRENDS. WITHOUT THE COMPLAINT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUES OR IDENTIFY THEIR ROOT CAUSES. NO CORRECTIVE AND PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE AND NO SYSTEMIC TREND HAS BEEN OBSERVED. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE INSERTER BECOMES AVAILABLE AT A LATER DATE, THE COMPLAINT WILL BE REOPENED AND THE SAMPLE WILL BE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE MONARCH CAP INSERTER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. FRACTURE ANALYSIS FOUND EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE. A REVIEW OF THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. COMPLAINT TREND ANALYSIS FOUND NO SYSTEMIC ISSUES REQUIRING IMMEDIATE ACTION. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED HOWEVER, FRACTURE ANALYSIS FOUND EVIDENCE OF TORSIONAL OVERLOAD. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    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

    DEVICE MFG. DATE: JULY-28-2006, JUNE-20-2006 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

    INTERNATIONAL AFFILIATE REPORTED THAT IT WAS NOTICED BEFORE SURGERY THAT THE MONARCH CAP INSERTER AND THE MONARCH SHORT CAP INSERTER WERE DAMAGED AT THE TIPS. IT WAS LATER REVEALED THAT THE TABS ON THE DISTAL TIPS OF THE CAP INSERTERS WERE CLEANLY BROKEN OFF THE INSTRUMENTS INTRA-OPERATIVELY AND WERE RETRIEVED FROM THE PATIENT. THE NURSE PUT THE BROKEN TABS IN HER SHARPS DISH AND DISCARDED THEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE MONARCH CAP INSERTER AND MONARCH SHORT CAP INSERTER THAT WERE INVOLVED IN THIS EVENT: 1526439-2014-11956; 1526439-2014-11957.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620269 MONARCH CAP INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE T0606

    Patients

    Seq Age Sex Outcome Treatment
    1