BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 5371012 · Received January 15, 2016

    Report

    Report Number
    1719045-2016-10070
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Report Date
    December 30, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; 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

    DATE OF EVENT: UNKNOWN. PRODUCT INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE TIP OF A MATRIX LOCKING HOLDING SLEEVE-LONG (03.616.042) BROKE DURING STERILIZATION. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE RETURNED HOLDING SLEEVE (03.616.042 / LOT 6921274) WAS EXAMINED UPON RECEIPT AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL TIP WAS FOUND TO BE BROKEN AND MISSING A SEGMENT. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF AN OFF-AXIS LOAD WHILE ENGAGING A SCREW AND/OR ROUGH HANDLING. THE MATRIX LOCKING HOLDING SLEEVE-LONG IS ONE OF TEN (10) HOLDINGS SLEEVES FOR THE MATRIX SPINE SYSTEM UTILIZED DURING SCREW INSERTION. THE MATRIX SYSTEM IS COVERED BY THREE TECHNIQUE GUIDES: MATRIX ¿ DEFORMITY, MATRIX-DEGENERATIVE, AND MATRIX ¿ MIS. THE LOCKING HOLDING SLEEVES ARE ALTERNATE INSTRUMENTS NOTED IN THE MATRIX 5.5 TECHNIQUE ADDITION. ONCE THE LOCKING HOLDING SLEEVE IS ENGAGED WITH THE DRIVER SHAFT, IT CAN BE THREADED INTO THE PROXIMAL END OF THE MATRIX SCREW BY ROTATING THE HOLDING SLEEVE¿S SILVER KNOB CLOCKWISE UNTIL IT IS FULLY ENGAGED. ONCE FULLY ENGAGED THE GREEN LOCKING RING CAN BE ENGAGED BY DEPRESSING TOWARDS THE SILVER KNOB. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE THREADED TIP WAS FOUND TO BE BROKEN AND MISSING A SEGMENT (APPROXIMATELY 6MM X 4MM). NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF AN OFF-AXIS LOAD WHILE ENGAGING A SCREW. ADDITIONALLY, THE INSTRUMENT WAS RETURNED WITHOUT AN OUTER SLEEVE. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: TOP-LEVEL AND INNER SHAFT. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBERS AND NO COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DATE REC'D BY MFR: THE DATE OF DEVICE RETURN WAS ORIGINALLY REPORTED AS JANUARY 24, 2016 IN ERROR. THE CORRECT DATE OF RETURN WAS JANUARY 21, 2016. THE DATE HAS BEEN UPDATED IN THE ASSOCIATED FIELD. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW - PART NUMBER: 03.616.043. LOT NUMBER: 6921274. RELEASE TO WAREHOUSE DATE: NOVEMBER 5, 2012. MANUFACTURING SITE IS (B)(4) AND SUPPLIED BY (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE THREAD AT THE TIP OF A LOCKING HOLDING SLEEVE DEVICE BROKE DURING THE CLEANING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30343 LOCKING HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6921274

    Patients

    Seq Age Sex Outcome Treatment
    1