BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE 55MM

    MDR report key: 5666051 · Received May 19, 2016

    Report

    Report Number
    1719045-2016-10417
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Report Date
    May 5, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT OR PROCEDURAL INVOLVEMENT. IT IS UNKNOWN WHEN THE REPORTED MALFUNCTIONS ACTUALLY OCCURRED; HOWEVER, THE ISSUES WERE DISCOVERED DURING INVENTORY MAINTENANCE ON MAY 5, 2016. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: FEBRUARY 21, 2011 NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: PARTS 2 THROUGH 6: FIVE (5) HOLDING SLEEVES AND FOUR (4) INDIVIDUAL WINGS SCREW WERE RECEIVED. EACH WING SCREW WAS TESTED WITH EACH HOLDING SLEEVE AND ONLY IN TWO CASES COULD A WING SCREW BE FULLY THREADED INTO THE SLEEVE COMPONENT OF THE HOLDING SLEEVE. PARTS 2 THROUGH 6 (394.46/394.45): THE CONDITION OF EACH OF THE HOLDING SLEEVES AND WING NUTS IS CONSISTED WITH SIGNIFICANT USE AND EXCESSIVE TIGHTENING BASED ON THE NOTED INDENT ON THE DISTAL FLAT. 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 AN INVENTORY CHECK AND BASIC MAINTENANCE WAS BEING CARRIED OUT BY STERILE PROCESSING ON MAY 5, 2016. DURING THIS CHECK, TWELVE (12) DEVICES FROM A LARGE DISTRACTOR SET ON CONSIGNMENT WERE FOUND IN NEED OF REPLACEMENT OR REPAIR. THERE WAS NO REPORTED PATIENT OR PROCEDURAL INVOLVEMENT. ALL TWELVE (12) DEVICES WERE ASSESSED FOR REPORTABILITY, BUT ONLY SEVEN (7) MET THE CRITERIA FOR REPORTING AT THIS TIME. THEY ARE AS FOLLOWS: PART 394.46 / LOT UNKNOWN / QUANTITY: 1 ¿ STRIPPED; PART 394.45 / LOT 2271105 / QUANTITY: 1 ¿ STRIPPED; PART 394.45 / LOT 2049 / QUANTITY: 1 ¿ STRIPPED; PART 394.45 / LOT 2241769 / QUANTITY: 1 ¿ STRIPPED; PART 394.46 / LOT 9281665 / QUANTITY: 1 ¿ STRIPPED; PART 328.010 / LOT 1834593 / QUANTITY: 1 ¿ BROKEN; PART 319.006 / LOT A4JY261 / QUANTITY: 1 ¿ BROKEN TIP. THIS REPORT IS 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321036 HOLDING SLEEVE 55MM GUIDE FZX SYNTHES MONUMENT 2271105

    Patients

    Seq Age Sex Outcome Treatment
    1