BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 4841645 · Received June 12, 2015

    Report

    Report Number
    1719045-2015-10381
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 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

    PRODUCT INVESTIGATION SUMMARY: THE HOLDING SLEEVE (03.632.036 / LOT 7212999) AND MATRIX SCREW (04.632.545 / LOT 7281007) WERE REVIEWED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS A FRAGMENT OF THE DISTAL TIP OF THE HOLDING SLEEVE WAS RETAINED BY THE RETURNED SCREW. THE ROOT CAUSE IS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION; HOWEVER, THE FAILURE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE, OFF-AXIS LOADING OR OVER-THREADING. THE HOLDING SLEEVE (03.632.036 / LOT 7212999) AND MATRIX SCREW (04.632.545 / LOT 7281007) WERE REVIEWED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS A FRAGMENT OF THE DISTAL TIP OF THE HOLDING SLEEVE WAS RETAINED BY THE RETURNED SCREW. THE ROOT CAUSE IS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION, HOWEVER, THE FAILURE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE, OFF-AXIS LOADING OR OVER-THREADING. AS NO ALLEGATIONS WERE MADE AGAINST THE RETURNED SCREW AS IT FUNCTIONED AS INTENDED; NO FURTHER EVALUATION IS REQUIRED. THE ASSOCIATED DRAWINGS FOR THE SLEEVE WERE REVIEWED DURING THE EVALUATION. CHANGES WERE 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 JULY 2011, AFTER THESE CHANGES WERE APPLIED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS 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

    ADDITIONAL NARRATIVE: PATIENT IDENTIFIER, DATE OF BIRTH/AGE, AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR 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. DEVICE HISTORY REVIEW: LOT 7212999 - RELEASED MAY 8, 2013. AVALIGN TECHNOLOGIES ¿ NEMCOMED DIVISION MANUFACTURED THE HOLDING SLEEVE ¿ LONG FOR MATRIX (PART 03.632.036 / LOT 7212999). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED MAY 3, 2011) INDICATES THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. NO NON-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE NURSE ATTEMPTED TO LOAD A SCREW ONTO THE INSERTION SCREWDRIVER (LONG T-HANDLE T25 STARDRIVE SHAFT WITH LONG HOLDING SLEEVE), BUT THE SCREW FAILED TO LOAD PROPERLY DURING A T12 ¿ L3 LUMBAR FUSION PROCEDURE. UPON EXAMINATION OF THE HOLDING SLEEVE, IT WAS DETERMINED THAT DAMAGE TO THE DISTAL END OF THE SLEEVE, WHERE THE MALE THREADS ARE LOCATED, WAS PRESENT AND PREVENTED THE HOLDING SLEEVE FROM PROPERLY ENGAGING THE FEMALE THREADS OF THE BONE SCREW. THE NURSE PLACED THIS INSTRUMENT ASIDE AND USED ANOTHER LONG T-HANDLE T25 STARDRIVE SHAFT AND LONG HOLDING SLEEVE, WHICH RESOLVED THE PROBLEM. UPON FURTHER EXAMINATION, IT WAS DETERMINED THAT THE MALE THREADS OF THE HOLDING SLEEVE SHEARED OFF AND WERE LODGED INTO THE PEDICLE SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385387 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 7212999

    Patients

    Seq Age Sex Outcome Treatment
    1