BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM

    MDR report key: 12518039 · Received September 23, 2021

    Report

    Report Number
    0009613350-2021-00487
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    July 30, 2021
    Report Date
    September 23, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505902
    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

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X42MM; CATALOG#: 47248604240; LOT#: 3010651. BLUNT TIP SCREW, 4X44MM; CATALOG#: 47248604440; LOT#: 3024701. BLUNT TIP SCREW, 4X46MM; CATALOG#: 47248604640; LOT#: 3008267. CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47248612440; LOT#: 3054478. CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47248612640; LOT#: 3039758. CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47248612640; LOT#: 3054456. CORTICAL BONE SCREW, 4X28MM; CATALOG#: 47248612840; LOT#: 3048195. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47248801000; LOT#: 3054441. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN . LG CANN SCREWDRIVER HANDLE; CATALOG#: 214149000; LOT#: UNKNOWN . THERAPY DATE: (B)(6) 2021. INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY IMPLANTATION OF A AFFIXUS NATURAL PROXIMAL HUMERAL NAIL ON (B)(6) 2021. 11 WEEKS POST SURGERY, IT WAS OBSERVED THAT THE PROXIMAL SCREWS HAD GRADUALLY BACKED OUT FROM THE ORIGINAL POSITION. THEREFORE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021, WHEREBY ALL OF THE PROXIMAL SCREWS WERE EXPLANTED. THE CORELOCK MECHANISM WAS REPORTED AS BEING ENGAGED USING THE TORQUE LIMITING DRIVER AFTER ALL THE INTERLOCKING SCREWS WERE PLACED. ADDITIONALLY, A NON-TORQUE LIMITING DRIVER WAS USED FOR ADDITIONAL TIGHTENING. 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: ONE UNLABELED FLUOROSCOPY IMAGE OF THE AFFECTED HUMERUS WAS RECEIVED. THE SECOND MOST PROXIMAL BLUNT TIP SCREW IS CONFIRMED TO HAVE MIGRATED. THE REPORTED EVENT INDICATES MULTIPLE PROXIMAL SCREWS HAVING MIGRATED. HOWEVER, NO ADDITIONAL PROXIMAL SCREWS CAN BE CONFIRMED TO HAVE MIGRATED DUE TO THE ANGLE THAT THE SINGLE IMAGE WAS TAKEN AND NO FURTHER VIEWS OF THE AFFECTED HUMERUS BEING PROVIDED. NEITHER A ASCENDING NOR A DESCENDING SCREW HAS BEEN IMPLANTED (ALSO IN ACCORDANCE TO THE PRODUCT IDS PROVIDED). 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. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT. SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE 197-GLBL-EN EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY IMPLANTATION OF A AFFIXUS NATURAL PROXIMAL HUMERAL NAIL ON (B)(6) 2021. 11 WEEKS POST SURGERY, IT WAS OBSERVED THAT THE PROXIMAL SCREWS HAD GRADUALLY BACKED OUT FROM THE ORIGINAL POSITION. THEREFORE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021, WHEREBY ALL OF THE PROXIMAL SCREWS WERE EXPLANTED. THE CORELOCK MECHANISM WAS REPORTED AS BEING ENGAGED USING THE TORQUE LIMITING DRIVER AFTER ALL THE INTERLOCKING SCREWS WERE PLACED. ADDITIONALLY, A NON-TORQUE LIMITING DRIVER WAS USED FOR ADDITIONAL TIGHTENING. 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). THE RECEIVED FLUOROSCOPY IMAGE CONFIRMS THE REPORTED EVENT, NAMELY THAT AT LEAST ONE OF THE PROXIMAL SCREWS HAS MIGRATED/BACKED OUT. HOWEVER, NO ADDITIONAL PROXIMAL SCREWS CAN BE CONFIRMED TO HAVE MIGRATED DUE TO THE ANGLE THAT THE SINGLE IMAGE WAS TAKEN AND NO FURTHER VIEWS OF THE AFFECTED HUMERUS BEING PROVIDED. THE LOCKING OF THE CORELOCK DURING THE IMPLANTATION HAS NOT BEEN PERFORMED AS SPECIFIED IN THE SURGICAL TECHNIQUE USING ONLY THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. INSTEAD, ADDITIONALLY A NON-TORQUE LIMITING SCREWDRIVER WAS USED. IT REMAINS UNKNOWN WHAT THE POTENTIAL EFFECT OF THIS DEVIATION FROM THE SURGICAL TECHNIQUE COULD BE AND HOW OR IF THIS POSSIBLY COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED FOR THE TIME BEING AND ZIMMER (B)(4) MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE. 11 WEEKS FROM THE INITIAL SURGERY IT WAS OBSERVED THAT THE PROXIMAL SCREWS HAD GRADUALLY BACKED OUT FROM THE ORIGINAL POSITION. HENCE, PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE BACKED OUT SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415958 PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3031577 00889024505902

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R