BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREW, 8 MM, 21 MM, HEX 3.5 MM

    MDR report key: 8446671 · Received March 24, 2019

    Report

    Report Number
    0009613350-2019-00146
    Event Type
    Injury
    Date Received
    March 24, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 16, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024298620
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: ADDITIONAL: H2 - H6. CORRECTION: B4 - D10 - G4 - G7 - H10. EVENT: IT WAS REPORTED THAT THE SET SCREW WAS STUCK DURING THE PROCEDURE, ALSO A SECOND TRY WITH ANOTHER SET SCREW WAS NOT SUCCESSFUL. IT IS UNKNOWN HOW THE LAG SCREW WAS FIXED BUT ONE SET SREW WILL BE RETURNED. HARM: EXTENDED SURGERY TIME T > 30MIN. HAZARD: DOES NOT FIT OR FUNCTION. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO RELEVANT MEDICAL DATA HAS BEEN RECEIVED. VISUAL EXAMINATION: ONLY HE SET SCREW HAS BEEN RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWS THAT THE FIRST AND SECOND THREAD OF THE SCREW IS POLISHED. THIS CAN BE CAUSED BY TRYING TO INSERT THE SET SCREW INTO THE ZNN NAIL. IT CAN BE ASSUMED THAT THE SET SCREW WAS NOT CORRECTLY PLACED INTO THE ZNN NAIL. NO OTHER DAMAS OR DEFORMATIONS CAN BE SEEN. FUNCTIONAL TES: A FUNCTIONAL TEST WAS DONE WITH THE AFFECTED SET SCREW AND ZNN NAIL (SAMPLE) REF 47-2493-182-13 LOT 2626396. THE SET SCREW COULD BE INSERTED INTO THE ZNN NAIL. THE FUNCTION OF THE DEVICE IS NOT AFFECTED. THE PRODUCTS ARE INTENDED FOR TREATMENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350 - 2019 - 00146.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM NUMBER: 47249336011, ITEM NAME Z NAIL CPM 11.5MM X 36CM 125 R, LOT# 2811445R; ITEM NUMBER: 47248511010, ITEM NAME Z NAIL 10.5 X 110 LAG SCREW, LOT # 2811286. THE MANUFACTURER DID NOT RECEIVE X-RAYS BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WAS STUCK DURING THE PROCEDURE, ALSO A SECOND TRY WITH ANOTHER SET SCREW WAS NOT SUCCESSFUL CAUSING A DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239787 SET SCREW, 8 MM, 21 MM, HEX 3.5 MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 15173132 00889024298620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other