BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3922123 · Received July 9, 2014

    Report

    Report Number
    1719045-2014-10298
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. THE DEVICE HISTORY REVIEW SHOWS, THE PARTS WERE MADE FROM THE SYNTHES TABULATED PRODUCT DRAWING # 03.632.001, RELEASED ON APRIL 05, 2011, WHICH INCLUDES PART NUMBER 03.632.036. THE CERTIFICATE OF COMPLIANCE, DATED JUNE 24, 2011, INDICATES THE PARTS WERE MANUFACTURED AND CONFORMED TO MATERIAL REQUIREMENTS AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS, PER P/N 03.632.036 (MADE FROM THE SYNTHES TABULATED PRODUCT DRAWING 03.632.001, RELEASED ON APRIL 06, 2011). PO # (B)(4), DATED JULY 25, 2011, FOR (B)(4) PARTS. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE, DATED JULY 22, 2011, INDICATES THE PARTS WERE MANUFACTURED AND CONFORMED TO MATERIAL REQUIREMENTS AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS, PER P/N 03.632.036, (MADE FROM THE SYNTHES TABULATED PRODUCT DRAWING 03.632.001, RELEASED ON JULY 12, 2011).THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON JULY 29, 2011. THE HOLDING SLEEVE-LONG FOR MATRIX WAS MADE TO THE SYNTHES TABULATED DRAWING P/N 03.632.001, RELEASED ON JULY 12, 2011 (WHICH INCLUDES P/N 03.632.036). 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RECEIVED PART 03.632.036 LOT 6611823 WAS RETURNED WITH THE COMPLAINT THAT SCREWDRIVER SLEEVES WERE NOT ENGAGING THE SCREWS. THIS DEVICE IS MISSING A LEVEL OF THREADING FROM THE DISTAL TIP WITH SIGNS THAT IT EITHER PEELED OFF HELICALLY OR WAS SHORN OFF. THE ASSOCIATED DRAWINGS WERE REVIEWED. CHANGES WERE MADE IN APRIL 2011, TO ADDRESS THE HAZARD OF THIS COMPLAINT FOR REDUCING THE OCCURRENCE. 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 RECEIVED INSTRUMENT WAS MANUFACTURED IN JULY 2011, AFTER THE IMPLEMENTATION OF THESE CHANGES. IN CONCLUSION, THIS COMPLAINT IS CONFIRMED AS THE TIP DAMAGE WOULD RESULT IN AN INABILITY TO ENGAGE THE SCREWS. 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 PATIENT WAS REVISED DUE TO ADJACENT LEVEL COMPLICATIONS. THE INITIAL LUMBAR FUSION SURGERY WAS A LEVEL L4-S1AND SCREWS, LOCKING CAPS AND RODS WERE IMPLANTED FROM LEVEL L4 TO S1 ON AN UNKNOWN DATE. DURING THE REVISION EXTENSION OF THE MATRIX HARDWARE PROCEDURE, FOR A LUMBAR FUSION AT LEVEL L3 AND ILIUM; THE SCREWDRIVER SLEEVES WERE NOT ENGAGING THE SCREWS WHEN THE SCRUB TECH WAS TRYING TO INSERT. THE SCRUB TECH CHANGED TO A SHORTER SCREWDRIVER BIT AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCESS. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE SLEEVES WERE BROKEN OFF PREVENTING IT FROM ENGAGING THE SCREW. IT WAS REPORTED THERE WAS A 10 MINUTE DELAY IN PROCEDURE AND THE PATIENT STATUS WAS FINE. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402104 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6611823

    Patients

    Seq Age Sex Outcome Treatment
    1