BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCREW, ÿ 4X28MM

    MDR report key: 13666846 · Received March 4, 2022

    Report

    Report Number
    0009613350-2022-00128
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505346
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010653. BLUNT TIP SCREW, 4X46MM; CATALOG#: 47-2486-046-40; LOT#: 3024714. BLUNT TIP SCREW, 4X60MM; CATALOG#: 47-2486-060-40; LOT#: 3054546. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47-2488-010-00; LOT#: 3033538. THE MANUFACTURER RECEIVED X-RAYS AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00126; 0009613350-2022-00127; 0009613350-2022-00129.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION INVESTIGATION RESULTS ARE NOW AVAILABLE. DURING THE INVESTIGATION IT WAS CONCLUDED THAT THE DEVICE PREVIOUSLY SUBMITTED ON THIS MEDWATCH IS NOT A CONTRIBUTING ELEMENT FOR THE REPORTED EVENT AND THEREFORE HAS BEEN MOVED TO CONCOMITANT DEVICE. PLEASE REMOVE 0009613350-2022- 00128 FROM YOUR RECORDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00126-1, 3068920 0009613350-2022-00129-1, 0009613350-2022- 00216, 0009613350-2022-00217. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 MONTHS FROM THE INITIAL, SURGEON FOUND A SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR.PATIENT INVOLVEMENT. NO FURTHER OUTCOME.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE. DURING THE INVESTIGATION IT WAS CONCLUDED THAT THE DEVICE PREVIOUSLY SUBMITTED ON THIS MEDWATCH IS NOT A CONTRIBUTING ELEMENT FOR THE REPORTED EVENT AND THEREFORE HAS BEEN MOVED TO CONCOMITANT DEVICE. PLEASE REMOVE 0009613350-2022- 00128 FROM YOUR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534025 CORTICAL BONE SCREW, ÿ 4X28MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3068488 00889024505346

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization SEE H10 NARRATIVE