BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED 5.5 ROD BENDERS

    MDR report key: 3142292 · Received June 3, 2013

    Report

    Report Number
    1526439-2013-18036
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE MODIFIED 5.5 ROD BENDER SET, PRODUCT CODE 6983-26-474, LOT NO: G0407, FOUND ON THE RIGHT HAND SIDE BENDER THAT BOTH DISTAL TIPS BROKE OFF. THE BROKEN PIECES WERE NOT RETURNED FOR EVALUATION. SIGNIFICANT MATERIAL DEFORMATION WAS ALSO OBSERVED IN THE AREA WHERE THE ROD CONTACTS THE BENDER ON BOTH ARMS. ON THE LEFT HAND SIDE BENDER: THE DISTAL TIP BROKEN ON ANGULATED ARM SECTION. THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. MODERATE MATERIAL DEFORMATION WAS ALSO OBSERVED IN THE AREA WHERE THE ROD CONTACTS THE BENDER ON BOTH ARMS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED THAT THE LOT WAS RELEASED TO STOCK ON 5/7/07 WITH A QUANTITY OF 1 SET; NO DISCREPANCIES WERE NOTED DURING THE RELEASE OF THIS SET. AS SUCH, A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A TWELVE MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MODIFIED 5.5 ROD BENDERS FOUND NO EMERGING TRENDS. THE ROOT CAUSE IS UNKNOWN. HOWEVER, THE TWO INSTRUMENTS IN THE SET WERE MOST LIKELY SUBJECTED TO A HIGHER THAN ANTICIPATED STRESS DURING THE AGGRESSIVE BENDING OF THE COBALT CHROME RODS. NO CORRECTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. BREAKAGE DID NOT OCCUR DURING A SURGICAL PROCEDURE. 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 ENDS OF TWO MONARCH BENDING ARM ASSEMBLIES BROKE OFF FROM THE INSTRUMENTS DURING USAGE. THE BROKEN SECTIONS WERE RETRIEVED FROM SURGICAL SITE WITH NO ADVERSE CONSEQUENCES AND NO SIGNIFICANT DELAY. THE INSTRUMENTS WERE DISCARDED BY THE CUSTOMER. SEE MFG MEDWATCH REPORT NO. 1526439-2013-18035, FOR THE OTHER MONARCH BENDING ARM ASSEMBLY THAT WAS INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE ENDS OF TWO SEPARATE MONARCH BENDING ARM ASSEMBLIES, BOTH CATALOG NUMBER 277030050 AND FILED ON MFG MEDWATCH REPORT NUMBERS 1526439-2013-18035 AND 1526439-2013-18036, BROKE OFF FROM THE INSTRUMENTS DURING USAGE. IT WAS REPORTED THAT THE BROKEN SECTIONS WERE RETRIEVED FROM THE SURGICAL SITE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY. IT WAS ALSO REPORTED THAT THE INSTRUMENTS WERE DISCARDED BY THE CUSTOMER. HOWEVER, CORRECTED EVENT INFORMATION HAS BEEN RECEIVED THE SALES REPRESENTATIVE. THE LEFT AND RIGHT HAND BENDERS ARE FROM ONE SET, CATALOG NUMBER 698326474, LOT G0407. IT IS REPORTED THAT THE BENDERS BROKE WHEN BENDING COBALT CHROME RODS AGGRESSIVELY IN A DEMONSTRATION LAB. THE BENDERS WERE NOT BEING USED IN SURGERY AT THE TIME OF BREAKAGE. THE SET CONTAINING THE TWO INSTRUMENTS WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243352 MODIFIED 5.5 ROD BENDERS BENDER LXH DEPUY SYNTHES SPINE G0407

    Patients

    Seq Age Sex Outcome Treatment
    1