BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 25240728 · Received May 21, 2026

    Report

    Report Number
    8030965-2026-04799
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    October 14, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (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: ÖZTÜRK T, GEDIKBAS M, ERPALA F, ASÇI M. ROUTINE TRANSPOSITION OR IN SITU DECOMPRESSION? RETHINKING ULNAR NERVE STRATEGY IN DISTAL HUMERUS FRACTURES. J CLIN MED. 2025 OCT 14;14(20):7233. DOI: 10.3390/JCM14207233. PMID: 41156103; PMCID: PMC12565325. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE POSTOPERATIVE FREQUENCY OF ULNAR NEUROPATHY (UN) IN PATIENTS TREATED WITH EITHER ANTERIOR TRANSPOSITION OR IN SITU DECOMPRESSION (ISD) OF THE ULNAR NERVE DURING ORIF OF DISTAL HUMERUS FRACTURES (DHFS). THE SECOND PURPOSE IS TO INVESTIGATE THE EFFECT OF ANTERIOR TRANSPOSITION (AT) IN PATIENTS WITH PRESENCE OF UN PREOPERATIVELY. BETWEEN JANUARY 2018 AND JANUARY 2022, A TOTAL OF 68 PATIENTS (42 MALE AND 26 FEMALES) WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 46.3 YEARS (20¿77 YEARS). THE MEAN FOLLOW-UP WAS 53 MONTHS (36¿76 MONTHS). OSTEOSYNTHESIS WAS PERFORMED ON ALL PATIENTS USING ANATOMIC ELBOW PLATES (ACUMED, HILLSBORO, OR, USA). AFTER COMPLETION OF THE OPERATION, OSTEOSYNTHESIS OF OLECRANON OSTEOTOMY WAS PERFORMED IN 55 PATIENTS WITH TENSION BAND TECHNIQUE (CANNULATED SCREW (SYNTHES, DEPUY, MA, USA) IN N=42 OR KIRSCHNER WIRES IN N=13). THE DECISION TO PERFORM EITHER ISD OR AT WAS MADE ACCORDING TO THE NERVE STATUS AND THE SURGEON¿S CHOICE INTRAOPERATIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CANNULATED SCREWS. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: ANATOMIC ELBOW PLATES (ACUMED) AND K-WIRES (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: CANNULATED: TRAUMA (QTY 3): (N=1) UNKNOWN NUMBER OF PATIENTS HAD ULNAR NEUROPATHY, OF WHICH PERSISTENT ULNAR NEUROPATHY LED TO REOPERATION. (N=1) UNKNOWN NUMBER OF PATIENTS SHOWED INTOLERANCE TO THE SCREWS NECESSITATING REMOVAL. (N=1) UNKNOWN NUMBER OF PATIENTS DEVELOPED NONUNION AFTER OLECRANON OSTEOTOMY WERE TREATED WITH GRAFTING USING AUTOGENOUS TRICORTICAL AND CANCELLOUS BONE HARVESTED FROM THE ILIAC CREST, AND RE-OSTEOSYNTHESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523469 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1