BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC REDUCTION INSTRUMENT SET GRAPHIC CASE

    MDR report key: 5401484 · Received February 1, 2016

    Report

    Report Number
    2520274-2016-10596
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 11, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND DHR REVIEW FOR PART# 306.05 WAS CONDUCTED. THE REPORT INDICATES THAT THE SUPPLIER LOT# 656394, SYNTHES LOT# 5282942, RELEASE TO WAREHOUSE DATE: 10JUL2006. SUPPLIER- (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE FOLLOWING DEVICE(S) WERE RECEIVED JAN 27, 2016, PELVIC REDUCTION INSTRUMENT SET (PART # 306.05 / LOT # 5282942), THE RETURNED DEVICE SHOES SIGNIFICANT DAMAGE AND MARKS CONSISTENT WITH HEAVY USE OVER ITS 9.5 YEAR LIFESPAN. TWO OF THE MAROON CORNER POSTS (COMPONENT Z9427A) HAVE BROKEN OFF AND THE LID IS MISSING ON ONE OF THE LOCKING TABS. ALL PIECES WERE NOT RETURNED. THE EXTERIOR CASE AS WELL AS THE INSIDE TRAYS IS HEAVILY DISCOLORED AND WORN. THIS DAMAGE IS CONSISTENT WITH REPEATED USE AND STERILIZATION CYCLES OVER THE LIFE OF THE DEVICE. THE CAUSE OF THIS COMPLAINT CONDITION IS DETERMINED TO BE WEARING OVER THE LIFE OF THE DEVICE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. UPDATED INFORMATION FOR THE PART & LOT NUMBER. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    UDI: THE FINISHED DEVICE WAS MANUFACTURED AND LABELED PRIOR TO THE COMPLIANCE DATE ESTABLISHED BY THE FDA FOR UNIQUE DEVICE IDENTIFICATION (UDI). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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

    IT WAS REPORTED THERE IS A COMPLAINT INVOLVING PARTS FROM THE PELVIC REDUCTION INSTRUMENT CASE. THE PRESS-FIT TYPE NIPPLES ON THE LID BROKE-OFF. IT IS UNKNOWN WHERE THEY ARE. LID WILL NOT STAY ON CASE. THIS WAS IDENTIFIED WHEN GOING THROUGH EQUIPMENT; THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60167 PELVIC REDUCTION INSTRUMENT SET GRAPHIC CASE TRAY,SURGICAL INSTRUMENT FSM SYNTHES MONUMENT 5282942

    Patients

    Seq Age Sex Outcome Treatment
    1