BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX

    MDR report key: 5531659 · Received March 29, 2016

    Report

    Report Number
    1719045-2016-10262
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Report Date
    February 9, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. (B)(4) USED TO CAPTURE THAT THIS DEVICE SHOWED SIGNS OF MATERIAL DEFORMATION. IT IS UNKNOWN IF THE PEELING OR THE BROKEN TIP AFFECTED THIS PART AS ALL FOUR RETURNED MATRIX HOLDING SLEEVE DEVICES HAD THE SAME PART/LOT NUMBERS. PRODUCT INVESTIGATION SUMMARY: THE RETURNED INSTRUMENTS WERE EXAMINED AND THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED FOR NINE (9) OF THE FOURTEEN (14) DEVICES. DURING THE INVESTIGATION, ALL FOUR MATRIX HOLDING SLEEVES (PART 03.632.123) WERE FOUND TO HAVE DAMAGED THREADED DISTAL TIPS (TWO PEELING AND TWO BROKEN WITH MISSING SEGMENTS). THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED: TOP-LEVEL AND INNER SHAFT. A DESIGN CHANGE 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; THE RETURNED INSTRUMENTS WERE MANUFACTURED AFTER THESE CHANGES WERE APPLIED. THE PRODUCTS WERE DISCOVERED DURING SET CHECK. AS METHOD OF USE AT THE TIME OF FAILURE IS UNKNOWN, NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE HISTORY RECORD REVIEW: RELEASE TO WAREHOUSE DATE: JANUARY 14, 2014 REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ON JUNE 2, 2014, 52 OF THE 63 PARTS RECEIVED WERE RELEASED TO WAREHOUSE WITH 11 SCRAPED PER A NON-CONFORMANCE (NC) FOR INCONSISTENT SURFACE FINISH. THE SURFACE FINISH WAS INSPECTED AS A RESULT OF REWORK, WHICH AROSE FROM AN NC WHERE RESIDUAL MANUFACTURING OIL WAS IDENTIFIED DURING BIOCOMPATIBILITY TESTING. THE REWORK CALLED FOR THE DEVICES TO BE DISASSEMBLED INTO TWO SUBASSEMBLIES UPON RECEIPT AND VAPOR DEGREASED. NEITHER NC IS RELATED TO THE COMPLAINT CONDITION OF WORN/DAMAGED TIP AS SURFACE FINISH/BIOCOMPATIBILITY WILL NOT IMPACT MATERIAL STRENGTH. 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.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT FOURTEEN (14) DEVICES WERE FOUND TO BE WORN DURING ROUTINE SET INVESTIGATION. ADDITIONALLY, IT WAS NOTED THAT THE METAL WAS STARTING TO DEFORM. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT REPORTED. DURING THE TIME WHEN THE COMPLAINT WAS ORIGINALLY RECEIVED, ALL DEVICES WERE FOUND TO BE NON-REPORTABLE. UPON INSPECTION OF THE RETURNED DEVICES, HOWEVER, FIVE (5) WERE FOUND TO HAVE FURTHER DAMAGE THAT REQUIRED RE-ASSESSMENT FOR UPDATED REPORTABILITY DETERMINATIONS. THIS REPORT IS 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189234 HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 7474959

    Patients

    Seq Age Sex Outcome Treatment
    1