BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE 55MM

    MDR report key: 5666059 · Received May 19, 2016

    Report

    Report Number
    2520274-2016-12745
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Report Date
    May 5, 2016
    Manufacturer
    SYNTHES USA
    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

    ADDITIONAL NARRATIVE: 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. MANUFACTURING DATE IS UNKNOWN ¿ DEVICE OLDER THAN 15 YEARS. DEVICE HISTORY RECORD REVIEW: THE DHR IS NOT AVAILABLE AS DEVICE IS OLDER THAN 15 YEARS. AT THIS TIME, THE MANUFACTURING DOCUMENTS FOR INSTRUMENTS ARE ONLY STORED FOR 10 YEARS. THIS WAS ACCORDING TO POLICIES SURROUNDING THE FILING AND ARCHIVING OF SPECIFICATION DOCUMENTS. 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

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE LOT NUMBER 9281665 INDICATES COMPONENT 3742 WHICH IS PART OF THE COMPLETE PART AS DESCRIBED IN THE COMPLAINT. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13.JAN.2015. NO NCRS 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 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS VERBIAGE (ALREADY REPORTED) WITH THE FOLLOWING: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: FOR EACH DEVICE THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE METHOD OF USE AND MAINTENANCE AND THE CONDITIONS AT THE TIME OF THE DAMAGE ARE UNKNOWN. HOWEVER, EACH RECEIVED CONDITION SHOWS EVIDENCE FORCEFUL USE AND SIGNIFICANT WEAR. 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. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. PARTS 2 THROUGH 6 (394.46/394.45): 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 (B)(6) 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 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322375 HOLDING SLEEVE 55MM GUIDE FZX SYNTHES USA 2049

    Patients

    Seq Age Sex Outcome Treatment
    1