BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X44MM

    MDR report key: 19267165 · Received May 8, 2024

    Report

    Report Number
    0009613350-2024-00160
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505469
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: PRODUCT ID WAS PROVIDED FOR THREE SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE THREE SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604440 ¿ BLUNT TIP SCREW ¿ 3134530. UDI: (B)(4). MANUFACTURING DATE: OCT 13, 2022. EXPIRATION DATE: OCT 13, 2027. 47248604440 ¿ BLUNT TIP SCREW ¿ 3172800. UDI: (B)(4). MANUFACTURING DATE: JUNE 11, 2023. EXPIRATION DATE: JUNE 11, 2028. 47248604440 ¿ BLUNT TIP SCREW - 3174942. UDI: (B)(4). MANUFACTURING DATE: SEPTEMBER 12, 2023. EXPIRATION DATE: SEPTEMBER 12, 2028. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. TWO UNDATED RADIOGRAPHS WERE RECEIVED AND REVIEWED BY A RADIOLOGIST WITH THE FOLLOWING ASSESSMENT (NOTE THAT A THIRD RADIOGRAPH WAS RECEIVED AND ALSO ASSESSED BY A RADIOLOGIST, BUT IS RELATED TO OTHER CASE . (MDR361711- 0009613350-2024-0015, MDR361712- 0009613350-2024-00158). THE INITIAL 2 IMAGES DEMONSTRATE INTRAMEDULLARY NAIL AND SCREW FIXATION OF AN IMPACTED FRACTURE OF THE PROXIMAL RIGHT HUMERUS. THE THIRD MOST PROXIMAL SCREW (#3) IS RETRACTED INTO THE SOFT TISSUES (RELATED TO MDR361711- 0009613350-2024-0015, MDR361712- 0009613350-2024-00158). THERE IS NO HARDWARE FRACTURE. THE FINAL IMAGE DEMONSTRATES REMOVAL OF THIS SCREW WITHOUT CHANGE IN ALIGNMENT. BASED ON THE REVIEW OF THE RADIOLOGIST, THE RECEIVED RADIOGRAPHS DO NOT INDICATE PROXIMAL SCREW (#1) MIGRATION. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: JAPAN THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY ONE MONTH AFTER INITIAL IMPLANTATION DUE TO A PROXIMAL SCREW THAT WAS BACKED OUT FROM THE PROPER POSITION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141309 BLUNT TIP SCREW, ÿ 4X44MM AFFIXUS TRAUMA IMPLANT HSB ZIMMER GMBH N/A 3134530 00889024505469

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R 47248604440 ¿ BLUNT TIP SCREW ¿ 3172800.| 47248604440 ¿ BLUNT TIP SCREW ¿ 3174942.| 47249616011 ¿ ANN NAIL ¿ 3167003.