BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX

    MDR report key: 6216349 · Received December 30, 2016

    Report

    Report Number
    1719045-2016-10953
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10705034718958
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION HAS BEEN COMPLETED FOR PART# 03.632.037, LOT# 6702153. A VISUAL INSPECTION, DEVICE HISTORY RECORDS REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED. THE POLYAXIAL HEAD PLACEMENT TOOL (03.632.037) IS USED IN THE MATRIX DEGENERATIVE AND DEFORMITY SPINE SYSTEMS. THE TOOL IS USED TO RETRIEVE A POLYAXIAL HEAD FROM AN IMPLANT MODULE AND PLACE IT OVER A MATRIX BONE SCREW. THE TECHNIQUE GUIDES STATE THAT, TO ENSURE THE POLYAXIAL HEAD IS SECURELY ATTACHED TO THE BONE SCREW, THE USER IS TO GENTLY LIFT UP ON THE PLACEMENT TOOL AND ANGULATE THE POLYAXIAL HEAD. THE RETURNED POLYAXIAL TOOL WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE BLOCKER WAS FOUND TO BE MISSING FROM THE RETURNED INSTRUMENT. EVIDENCE OF LASER WELDING WAS APPARENT ON BOTH THE BLOCKED AND THE DISTAL PORTION OF THE OUTER SHAFT BODY. THE BLOCKER IS ONLY LASER WELDED TO HALF OF THE OUTER SHAFT BODY, MAKING IT VULNERABLE TO BREAKAGE IN THE AREA OF THE LASER WELD. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THESE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE MEDIUM INSERTER WAS FOUND TO HAVE MET THE DRAWINGS SPECIFICATIONS CONSISTENT WITH THEIR DATE OF MANUFACTURE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS AND IN EACH INSTANCE NO NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE IDENTIFIED AS METHOD OF USE AT THE TIME OF FAILURE WAS NOT SPECIFIED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    NO PATIENT INVOLVEMENT WAS REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.632.037, LOT# 6702153. SUPPLIER: (B)(4) MANUFACTURING, RELEASE TO WAREHOUSE DATE: (B)(6) 2011. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 THE TIPS WERE BROKEN ON THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX AND SELF-RETAINING SCREWDRIVER FOR QUICK LOCKS SCREWS. THIS WAS NOTICED DURING INSPECTION AND NOT IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866410 POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6702153 10705034718958

    Patients

    Seq Age Sex Outcome Treatment
    1