BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP SCREW, 4X40MM

    MDR report key: 13142251 · Received January 3, 2022

    Report

    Report Number
    0009613350-2022-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2022
    Date of Event
    December 3, 2021
    Report Date
    February 8, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505445
    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

    CONCOMITANT MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X46MM CATALOG#: 47-2486-046-40; LOT#: 3024720. CORTICAL BONE SCREW, 4X22MM CATALOG#: 47-2486-122-40; LOT#: 3076794. CORTICAL BONE SCREW, 4X24MM CATALOG#: 47-2486-124-40; LOT#: 3076810. PROXIMAL HUMERUS NAIL CAP, 0MM CATALOG#: 47-2488-010-00; LOT#: 3068908. X-RAYS RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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 CMP-0760980. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00001; 0009613350-2022-00002; 0009613350-2022-00004 H3 OTHER TEXT : REMAINS IMPLANTED

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: A1, A2, A3, E1, H2, H6, H10. EVENT DESCRIPTION: IT WAS REPORTED THAT ONE WEEK AFTER IMPLANTATION, ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. NO REVISION IS PLANNED. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: THE PROVIDED X-RAYS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW FOUND THAT THERE IS AN INTRAMEDULLARY NAIL WITH PROXIMAL AND DISTAL SCREW FIXATION THAT TRAVERSES A HUMERAL NECK FRACTURE. ON THE LEFT IMAGE (DATED (B)(6) 2021), THE MOST PROXIMAL SCREW HAS BACKED OUT. THE FRACTURE ALIGNMENT IS MAINTAINED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE SAP: IDENTIFIED THAT THE INTERLOCKING SCREWS SHOULD BE LOCKED USING THE CORELOCK DRIVER AFTER THE PLACEMENT OF ALL SCREWS. IT WAS NOTED THAT THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE. CONCLUSION: IT WAS REPORTED THAT ONE WEEK AFTER IMPLANTATION, ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. NO REVISION IS PLANNED. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. 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 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

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH NAIL ON. AFTER 1 WEEK FROM THE INITIAL, SURGEON FOUND 1 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 OUTCOME UNDER OBSERVATION.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643333 BLUNT TIP SCREW, 4X40MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3054465 00889024505445

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SEE H10 NARRATIVE