BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X46MM

    MDR report key: 12407195 · Received September 1, 2021

    Report

    Report Number
    0009613350-2021-00444
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 18, 2021
    Report Date
    November 11, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505476
    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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. D10: MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X48MM; CATALOG#: 47-2486-048-40; LOT#: 3024731. PROXIMAL HUMERUS, RIGHT, 11X160MM; CATALOG#: 47-2496-160-11; LOT#: 3051302. BLUNT TIP SCREW, 4X46MM; CATALOG#: 47-2486-046-40; LOT#: 3062600. CORTICAL BONE SCREW, 4X32MM; CATALOG#: 47-2486-132-40; LOT#: 3010610. PROXIMAL HUMERUS NAIL CAP, 10.5X2.5MM; CATALOG#: 47-2488-010-02; LOT#: 3025182. PROXIMAL HUMERUS NAIL CAP,11X2.5MM; CATALOG#: 47-2488-011-02; LOT#: 3038374. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN . LG CANN SCREWDRIVER HANDLE; CATALOG#: 214149000; LOT#: UNKNOWN . THERAPY DATE: (B)(6) 2021. ADDITIONAL INFORMATION WHICH WAS RECEIVED ON SEP 03, 2021. ADDITIONAL: B5, D10, E1. CORRECTION: B4, G3, G6, H2, H10. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    IT HAS BEEN REALIZED DURING FURTHER INVESTIGATIONS THAT THIS DEVICE IS NOT THE MAIN PRODUCT. THE INCIDENT IS REPORTED WITH 0009613350-2021-00458 AND 0009613350-2021-00446. THEREFORE, THIS MDR IS OBSOLETE. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4)

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE WITH AN ANN NAIL SYSTEM. A WEEK POST THE IMPLANTATION SURGERY THE SURGEON NOTICED THAT THE THIRD BLUNT SCREW HAD BACKED OUT FROM ITS PROPER POSITION. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE THIRD BLUNT SCREW WAS EXPLANTED. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X48MM; CATALOG#: 47-2486-048-40; LOT#: 3024731. PROXIMAL HUMERUS, RIGHT, 11X160MM; CATALOG#: 47-2496-160-11; LOT#: 3051302. BLUNT TIP SCREW, 4X46MM; CATALOG#: 47-2486-046-40; LOT#: 3062600. CORTICAL BONE SCREW, 4X32MM; CATALOG#: 47-2486-132-40; LOT#: 3010610. PROXIMAL HUMERUS NAIL CAP, 10.5X2.5MM; CATALOG#: 47-2488-010-02; LOT#: 3025182. PROXIMAL HUMERUS NAIL CAP,11X2.5MM; CATALOG#: 47-2488-011-02; LOT#: 3038374 . THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. 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).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE WITH AN ANN NAIL SYSTEM. A WEEK POST THE IMPLANTATION SURGERY THE SURGEON NOTICED THAT THE THIRD BLUNT SCREW HAD BACKED OUT FROM ITS PROPER POSITION. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE THIRD BLUNT SCREW WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301409 BLUNT TIP SCREW, 4X46MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3039376 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R