BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERUS, LEFT, 9X160MM

    MDR report key: 12049031 · Received June 23, 2021

    Report

    Report Number
    0009613350-2021-00308
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    September 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505810
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3054317 BLUNT TIP SCREW, 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3062682 BLUNT TIP SCREW, 4X40MM; CATALOG#: 47-2486-040-40; LOT#: 3064863 BLUNT TIP SCREW, 4X42MM; CATALOG#: 47-2486-042-40; LOT#: 3054544 CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 3054496 PROXIMAL HUMERUS NAIL CAP, 10.5X2.5MM; CATALOG#: 47-2488-010-02; LOT#: 3054395 CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 30224294 AFFIXUS PR HUM CORELOCK DRVR; CATALOG#: 110035663; LOT#: UNKNOWN. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN . INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, H6. CORRECTION: B4, B5, G3, G6, H10. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ZIMMER PRODUCTS ON MAY 06, 2021. 3 WEEKS POST THE IMPLANTATION, IT WAS NOTICED THAT THE PROXIMAL SCREW GOT LOOSE AND OUT OF THE NAIL, DAMAGING THE ARM SOFT TISSUE. REVISION SURGERY HAS NOT BEEN PERFORMED YET. REVIEW OF RECEIVED DATA: DUE DILIGENCE: FURTHER DUE DILIGENCE TO SUPPORT THE CONCLUSION WAS COMPLETED AND DOCUMENTED IN DILIGENCE LOG. X-RAYS: ONE UNDATED X-RAY IMAGE WAS PROVIDED FOR INVESTIGATION. IT SHOWS THE PROXIMAL END OF THE NAIL INCLUDING FOUR PROXIMAL LOCKING SCREWS. HOWEVER NO CONSPICUOUS FINDINGS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. IMAGES: ONE IMAGE WAS RECEIVED SHOWING THE PRODUCT STICKERS OF THE IMPLANTED PRODUCTS. HOWEVER NO CONSPICUOUS FINDINGS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RAW MATERIAL CERTIFICATE: THE RAW MATERIAL CERTIFICATE WAS REVIEWED WITH NO ANOMALIES NOTED. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ZIMMER PRODUCTS ON (B)(6) 2021. 3 WEEKS POST THE IMPLANTATION, IT WAS NOTICED THAT THE PROXIMAL SCREW GOT LOOSE AND OUT OF THE NAIL, DAMAGING THE ARM SOFT TISSUE. REVISION SURGERY HAS NOT BEEN PERFORMED YET. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. FROM THE AVAILABLE X-RAY NO CONSPICUOUS FINDINGS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INVESTIGATION THE REPORTED EVENT CANNOT BE CONFIRMED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED FOR THE TIME BEING AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3054317, BLUNT TIP SCREW, 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3062682, BLUNT TIP SCREW, 4X40MM; CATALOG#: 47-2486-040-40; LOT#: 3064863, BLUNT TIP SCREW, 4X42MM; CATALOG#: 47-2486-042-40; LOT#: 3054544, CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 3054496, PROXIMAL HUMERUS NAIL CAP, 10.5X2.5MM; CATALOG#: 47-2488-010-02; LOT#: 3054395, CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 30224294. THERAPY DATE: UNKNOWN. 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 AND 3 WEEKS POST IMPLANTATION, IT WAS NOTICED THAT THE PROXIMAL SCREW HAD GOTTEN LOOSE AND OUT OF THE NAIL DAMAGING THE ARM SOFT TISSUE. REVISION SURGERY HAS NOT BEEN PERFORMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951986 PROXIMAL HUMERUS, LEFT, 9X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3033566 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE.| SEE H10 NARRATIVE.