BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KELLY SCISSORS,STRAIGHT,16CM,6

    MDR report key: 6834781 · Received August 31, 2017

    Report

    Report Number
    0001032347-2017-00701
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 10, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EGN
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE SCISSORS (PART #51-0985, LOT #UNKNOWN) SHOWED SIGNS OF MODERATE WEAR. UPON INSPECTION THE INSTRUMENT WAS FOUND TO BE IN DECENT OVERALL CONDITION WITH SOME DISCOLORATION AND SCRATCHING DUE TO NORMAL WEAR. BOTH OF THE TIPS WERE FRACTURED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED DUE TO THE AGE OF THE POSSIBLE LOTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE INSTRUMENT EXPERIENCED EXCESSIVE FORCE BEYOND WHAT IT WAS DESIGNED TO ENCOUNTER. THE INSTRUCTIONS FOR USE (IFU) FOR GENERAL INSTRUMENTATION HAS THE FOLLOWING INFORMATION PROVIDED IN THE SECTION TITLED WARNINGS AND PRECAUTIONS: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. LOT NUMBER AND DEVICE MANUFACTURE DATE: THERE IS NO VISIBLE LOT ETCH ON THE PRODUCT. POTENTIAL LOTS THAT WERE SOLD TO THIS CUSTOMER ARE LOT 425065 MANUFACTURED 12/16/1996, LOT 511093 MANUFACTURED 2/16/1998, & LOT 535127 MANUFACTURED 2/16/1998.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP FRACTURED. THERE WAS NO INJURY AND NO DELAY. THE FRACTURED PIECES WERE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614474 KELLY SCISSORS,STRAIGHT,16CM,6 SCISSORS, SURGICAL TISSUE, DENTAL EGN BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention