BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT HUMERAL NAIL

    MDR report key: 24916053 · Received April 17, 2026

    Report

    Report Number
    8030965-2026-03570
    Event Type
    Injury
    Date Received
    April 17, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: RASBI AA, AMRI AA, HADEETHI AA, AGHBARI IA, SENANI OA. OUTCOMES OF INTRAMEDULLARY NAILING VERSUS PLATE FIXATION OF HUMERUS SHAFT FRACTURES: A SINGLE-CENTER RETROSPECTIVE STUDY. ADV ORTHOP. 2025 NOV 6;2025:8821939. DOI: 10.1155/AORT/8821939. PMID: 41210180; PMCID: PMC12592684. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE COHORT STUDY AIMED TO COMPARE THE FUNCTIONAL OUTCOMES AND COMPLICATIONS ASSOCIATED WITH IM NAILING AND PLATING FIXATION FOR HUMERAL SHAFT FRACTURES AT SULTAN QABOOS UNIVERSITY HOSPITAL INCLUDED ADULTS WHO UNDERWENT HUMERAL SHAFT FRACTURE FIXATION FROM JANUARY 2012 TO DECEMBER 2022. ABOUT 73 PATIENTS WERE INCLUDED IN THE STUDY, 37 OF WHOM UNDERWENT IM NAILING, AND 36 PATIENTS HAD PLATE FIXATION. IM NAILING CASES WERE DONE USING THE EXPERT HUMERAL NAILING SYSTEM DEVELOPED BY DEPUY SYNTHES, WHILE PLATING PROCEDURES WERE DONE USING NARROW 4.5-MM LIMITED CONTACT DYNAMIC COMPRESSION PLATES EITHER WITH AN ANTEROLATERAL APPROACH OR POSTERIOR APPROACH. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: EXPERT HUMERAL NAILING SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: EXPERT HUMERAL NAIL (QTY:15) (N=1) SURGICAL SITE INFECTIONS (SSI); NO INTERVENTION REPORTED. (N=1) DELAYED UNION; NO INTERVENTION REPORTED. (N=2) NONUNION; NO INTERVENTION REPORTED. (N=1) POSTOP RADIAL NERVE PALSY; NO INTERVENTION REPORTED. (N=5) REVISION OR IMPLANT REMOVAL; THE MAIN INDICATION FOR REVISION SURGERY IN THIS GROUP WAS NAIL PROTRUSION. (N=5) SHOULDER PAIN OR REDUCED ROM; NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398549 UNK - CONSTRUCTS: EXPERT HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1