BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL HEAD ELEMENTS: SCREW

    MDR report key: 22674996 · Received July 31, 2025

    Report

    Report Number
    8030965-2025-07849
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 6, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H.11. ADDITIONAL NARRATIVE: ADDED: B3, D4 (CATALOG). H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KABELITZ M, WALTENSPÜL M, DIETRICH M. LOWER CORTICAL THICKNESS INDEX DOES NOT CORRELATE WITH INCREASED SURGICAL COMPLICATIONS IN PROXIMAL FEMORAL FRACTURES: A CLINICAL AND RADIOLOGICAL STUDY. SCI REP. 2025 JUL 6;15(1):24115. DOI: 10.1038/S41598-025-09362-8. PMID: 40619545; PMCID: PMC12230136. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE WAS TO ASSESS THE ASSOCIATION BETWEEN A LOWER CTI AND THE OCCURRENCE OF PERI- AND POSTOPERATIVE SURGICAL COMPLICATIONS. FROM JULY 2022 UNTIL SEPTEMBER 2023, A TOTAL OF 228 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 171 FEMALE PATIENTS. DIVIDED INTO TWO GROUPS: TROCHANTERIC FRACTURE (TFX) GROUP CONSISTS OF 99 PATIENTS TREATED WITH INTRAMEDULLARY NAILING (TFNA, DEPUY SYNTHES, ZUCHWIL, SWITZERLAND)(AO/OTA 31A1.1¿31A2.3 AND FEMORAL NECK FRACTURE (FNFX) WITH 129 PATIENTS TREATED WITH HEMI-/TOTAL HIP ARTHROPLASTY (AO/OTA 31B1¿B3) (FNFX) WITH A MEAN AGE OF 82 ± 9.9 (50¿99) YEARS, THERE WERE TOTAL HIP ARTHROPLASTIES WERE IMPLANTED (AMISTEM C/H, MEDACTA INTERNATIONAL SA, CASTEL SAN PIETRO, SWITZERLAND; CEMENTED AND UNCEMENTED) FROM UNKNOWN MANUFACTURER. FOLLOW UP WERE UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES INTRAMEDULLARY NAILING TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TFNA (QTY 36) -18 PATIENTS (7.9%) WITH UNDERGOING REVISION SURGERY AMONG THE TOTAL NUMBER OF PATIENTS,10 (55.6%) EXHIBITED MECHANICAL COMPLICATIONS. THE REMAINING PATIENTS UNDERWENT A SUBSEQUENT REVISION DUE TO INFECTION (N = 4), SEROMA/HEMATOMA(N = 3), OR A RUNNING WOUND (N = 1);TREATMENT: NOT PROVIDED. -5 PATIENTS WITH INCISIONS OR EXTRACTIONS OF THE HELICAL BLADE ;TREATMENT: NOT PROVIDED. -5 PATIENTS (62.5%),REVEALED A DISRUPTION OF THE MEDIAL FEMORAL CALCAR; TREATMENT: NOT PROVIDED. -2 PATIENTS WITH TRACTUS IRRITATION THROUGH HELICAL BLADE LATERALISATION ;TREATMENT: NOT PROVIDED. -1 PATIENT WITH INTRAOPERATIVE FRACTURE ;TREATMENT: NOT PROVIDED. -5 PATIENTS (62.5%),REVEALED A DISRUPTION OF THE MEDIAL FEMORAL CALCAR; TREATMENT: NOT PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (QTY 5) -5 PATIENTS BECAUSE OF CLOSE TO OR ACTUAL HELICAL BLADE CUT-THROUGH/CUT-OUT);TREATMENT: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34929 UNK - NAIL HEAD ELEMENTS: SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention