BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 5166584 · Received October 21, 2015

    Report

    Report Number
    1719045-2015-10685
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    SYNTHES MONUMENT
    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

    PRODUCT INVESTIGATION SUMMARY: ONE RETAIN-SLEEVE LONG F/MATRIX 5.5 (PART 03.632.036 / LOT 6860569) WAS RECEIVED. PLEASE NOTE THAT A SCREW (PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM [PART 632.640 / LOT 7962198]) WAS RETURNED WITH THE INSTRUMENT; HOWEVER, NO ALLEGATION WAS MADE AGAINST THE SCREW. UPON VISUAL INSPECTION OF THE DEVICE, IT CAN BE SEEN THE HOLDING SLEEVE IS MISSING A PORTION OF THE THREADED TIP. VISUAL INSPECTION OF THE SCREW SHOWS THAT THE THREADED PORTION OF THE RETAINING SLEEVE IS STUCK ONTO THE TOP. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS CONSISTENT WITH ROUGH HANDLING OVER THE LIFE OF THE INSTRUMENT (3+ YEARS). THE COMPLAINT CONDITION IS CONFIRMED. BOTH THE RETAINING SLEEVE AND POLYAXIAL SCREW ARE PART OF THE MATRIX SPINE SYSTEM - A POSTERIOR PEDICLE SCREW, HOOK, AND ROD FIXATION SYSTEM. THE HOLDING SLEEVE IS USED FOR SCREW INSERTION ALONG WITH AN APPROPRIATE DRIVER. AND THE PEDICLE SCREW IS USED IN THE MATRIX SCREW SYSTEM TO SECURELY ANCHOR THE SCREW IMPLANTS IN BOTH THE CORTICAL AND CANCELLOUS BONY ANATOMY. THE RELEVANT DRAWING FOR THE SLEEVE WAS REVIEWED DURING THE EVALUATION. A CHANGE ORDER WAS IMPLEMENTED TO ADDRESS THE FAILURE MODE OF THE THREAD TIPS BREAKING. THE TIP GEOMETRY ON THE INNER SLEEVE WAS CHANGED TO A MORE CONSTANT OUTER DIAMETER AND THE MATERIAL OF THE OUTER SLEEVE CHANGED FROM RADEL PLASTIC TO ANODIZED TITANIUM. THE RETURNED INSTRUMENT WAS MANUFACTURED IN APRIL, 2012, AFTER THESE CHANGES WERE APPLIED. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO ISSUES WITH THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    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

    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 ¿ DHR REVIEW FOR PART#03.632.036 LOT#6860569. RELEASE TO WAREHOUSE DATE: (B)(6) 2012. SUPPLIER- AVALIGN TECHNOLOGIES-NEMCOMED. 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: A MATRIX SYSTEM WAS APPLIED FOR LUMBAR SPINAL CANAL STENOSIS AT LEGION OF L4-L5. DURING SCREW INSERTION PROCEDURE, IT WAS FOUND THE HOLDING SLEEVE WAS WRENCHED OFF AT ITS TIP OF THREAD PART. AS THE BROKEN TIP RESIDED IN THE SCREW, THE SURGEON REMOVED THE SCREW AND REPLACED WITH ANOTHER SCREW USING A DRIVER INSTEAD OF THE HOLDING SLEEVE. THE SURGERY WAS EXTENDED FOR 10 MINUTES. NO PATIENT HARM WAS REPORTED. REPORTEDLY, NO BROKEN PIECES REMAINED IN THE PATIENT'S BODY. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696905 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1