BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X40MM

    MDR report key: 17115407 · Received June 13, 2023

    Report

    Report Number
    0009613350-2023-00255
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 14, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505445
    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). D10: ITEM#: 47-2496-280-08; LOT#: 3123159; ITEM NAME: PROXIMAL HUMERUS, RIGHT, LONG, 8.5X280MM. ITEM#: 47-2486-042-40; LOT#: 3087855; ITEM NAME: BLUNT TIP SCREW, 4X42MM. ITEM#: 47-2486-044-40; LOT#: 3091417; ITEM NAME: BLUNT TIP SCREW, 4X44MM. ITEM#: 47-2486-124-40; LOT#: 3136308; ITEM NAME: BLUNT TIP SCREW, 4X44MM. ITEM#: 47-2486-124-40; LOT#: 3137797; ITEM NAME: BLUNT TIP SCREW, 4X44MM. ITEM#: 47-2488-010-00; LOT#: 3091320; ITEM NAME: BLUNT TIP SCREW, 4X44MM. ITEM#: 27923; LOT#: 3091320; ITEM NAME: TORQUE LIMITING HANDLE. G2-FOREIGN- JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 -2023 -00254, 0009613350 -2023 -00256, 0009613350 -2023 -00257. 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10. 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 THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. IMAGES WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. FLUOROSCOPIC IMAGE DEMONSTRATES THE PROXIMAL ASPECT OF A RIGHT HUMERAL IM NAIL AND PROXIMAL SCREW WITH ANATOMIC ALIGNMENT. RIGHT HUMERAL IMAGES DEMONSTRATE INTRAMEDULLARY NAIL AND SCREW FIXATION OF THE RIGHT HUMERUS WITH NEAR ANATOMIC ALIGNMENT OF THE DIAPHYSEAL FRACTURE. THE MOST PROXIMAL SCREW APPEARS TO HAVE RETRACTED SIGNIFICANTLY FROM THE HUMERUS BUT IS STILL ENGAGED BY THE NAIL. NO LOOSENING, WEAR OR ABNORMAL RADIOLUCENCY IS NOTED. IMPLANT FIT AND ALIGNMENT ARE MAINTAINED APART FROM RETRACTION OF THE MOST PROXIMAL SCREW AS NOTED. BONE QUALITY IS OSTEOPENIC PATIENT ANATOMY APPEARS UNREMARKABLE. THERE IS NO EVIDENCE OF INTERVAL TRAUMA. 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. OF NOTE, AS CONFIRMED FROM THE X-RAYS, NO ASCENDING SCREW WAS USED DURING SURGERY. THE USE OF THIS SCREW INCREASE PRIMARY STABILITY OF THE IMPLANT AND SUPPORTS THE HUMERAL HEAL DURING ABDUCTION. 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, ASCIENTIFIC 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 THESECOND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INITIAL SURGERY, THE PATIENT WAS IMPLANTED WITH ANN NAIL. 6 WEEKS AFTER THE SURGERY ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION AND THE PATIENT EXPERIENCED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998987 BLUNT TIP SCREW, 4X40MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURER GMBH 47-2486-040-40 3091516 00889024505445

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention| H SEE H10 NARRATIVE