BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X38MM

    MDR report key: 17179743 · Received June 22, 2023

    Report

    Report Number
    0009613350-2023-00311
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 22, 2023
    Report Date
    July 20, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505438
    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

    (B)(4). G2: FOREIGN- JAPAN. D10: ASSOCIATED PRODUCTS: ITEM REFERENCE: 47249624009, ITEM NAME: PROXIMAL HUMERUS, RIGHT, LONG, ÿ 10X240MM, ITEM LOT:3120152. ITEM REFERENCE: 47-2486-034-40, ITEM NAME:BLUNT TIP SCREW, ÿ4X34MM, ITEM LOT:3091296. ITEM REFERENCE: 47-2486-038-40, ITEM NAME:BLUNT TIP SCREW, ÿ4X38MM, ITEM LOT:3091505. ITEM REFERENCE: 47-2486-042-40, ITEM NAME:BLUNT TIP SCREW, ÿ4X42MM, ITEM LOT:3126148. ITEM REFERENCE: 47-2486-122-40, ITEM NAME:CORTICAL BONE SCREW, ÿ4X22MM, ITEM LOT:3087863. ITEM REFERENCE: 47-2486-122-40, ITEM NAME:CORTICAL BONE SCREW, ÿ4X22MM, ITEM LOT:3119233. ITEM REFERENCE: 47-2488-010-02, ITEM NAME:PROXIMAL HUMERUS NAIL CAP,ÿ 10.5X2.5MM, ITEM LOT:3091323. 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. 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. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT HUMERUS DEMONSTRATE A HUMERAL INTRAMEDULLARY ROD WITH THREE PROXIMAL INTERLOCKING SCREWS. PROXIMAL MOST INTERLOCKING SCREW HAS BACKED OUT ON THE SECOND IMAGE. OBLIQUE FRACTURE PROXIMAL HUMERAL DIAPHYSIS. 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, 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 FOUR (4) WEEKS AFTER IMPLANTATION OF SHOULDER NAIL, ONE OF THE PROXIMAL SCREWS HAS BACKED OUT FROM PROPER POSITION. IT IS NOT KNOWN WHICH ONE EXACTLY BACKED OUT. NO REVISION IS PLANNED SO FAR. 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
    68898 BLUNT TIP SCREW, ÿ 4X38MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3136318 00889024505438

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other SEE H10.