BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3072456 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10898
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(6) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE DEVICE WAS RETURNED WITH THE THREAD BROKEN. THE PART SHOWS ONE DEEP SCRATCH ON THE OUTER SHAFT AND NUMEROUS SCRATCHES, WEAR AND SCUFF MARKS ON THE VISIBLE PART OF THE INNER SHAFT. THE ABNORMALITIES ON THE LEAD THREAD, INSIDE CANNULATION AND GENERAL THREADED AREA PLUS THE BURRS PRESENT AROUND THE AREA OF THE BREAK INDICATE THE DEVICE HAS BEEN USED. DUE TO THE DAMAGE AND ALTERATION OF THE THREADED TIP, THE FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE MEASURED. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PRODUCT DEVELOPMENT EVALUATION DETAILS THE PART RETURNED WITH APPROXIMATELY ONE (1) FULL THREAD HAS PEELED AWAY FROM OF THE DISTAL TIP OF THE INSTRUMENT. OTHER THAN THIS, THERE IS NO VISIBLE DAMAGE OR DEFORMITY NOTED TO THE INSTRUMENT. THE DEVICE FUNCTIONS INDEPENDENTLY AS INTENDED. THE FAILURE MECHANISM DISPLAYED BY THE DAMAGED INSTRUMENT CAN ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD. THE CONDITION OF THE THREADS INDICATES THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THIS INCOMPLETE ENGAGEMENT ALLOWED THE CANTILEVER FORCE TO CONCENTRATE ON ONE SECTION OF THE IDENTIFIED THREADS, EXCEEDING THE DESIGN¿S TENSILE LIMITS. NO OTHER EVIDENCE OF DAMAGE WAS OBSERVED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION AT L1-L5 PROCEDURE, THE THREADS ON THE DISTAL TIPS OF THE HOLDING SLEEVE BROKE OFF. BROKEN FRAGMENT WAS RETRIEVED. WHILE INSERTING THE PEDICLE SCREW, THE TIPS OF THE SCREWDRIVERS ROUNDED OFF. SURGEON USED ANOTHER HOLDING SLEEVE AND SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS NO ADVERSE EFFECT TO PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175112 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6738069

    Patients

    Seq Age Sex Outcome Treatment
    1