BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: CANNULATED: TRAUMA

    MDR report key: 25317465 · Received May 28, 2026

    Report

    Report Number
    8030965-2026-04918
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: MENNEN AHM, BOON J, HALM JA, PETERS RW, BLOEMERS FW, VAN EMBDEN D. CLINICAL AND PATIENT-FOCUSED OUTCOMES AFTER PERCUTANEOUS SCREW FIXATION OF PELVIC RING FRACTURES IN OLDER ADULTS. J CLIN MED. 2025 JUN 3;14(11):3919. DOI: 10.3390/JCM14113919. PMID: 40507681; PMCID: PMC12155743. OBJECTIVE/METHODS/STUDY DATA: THE MAIN PURPOSE OF THIS STUDY WAS TO DESCRIBE PATIENT-FOCUSED OUTCOMES IN TERMS OF POST-OPERATIVE PAIN RELIEF, FUNCTIONAL PERFORMANCE, AND PATIENT SATISFACTION IN A COHORT OF OLDER ADULT PATIENTS WITH PELVIC RING FRACTURES AFTER BOTH HIGH- AND LOW-ENERGY TRAUMA THAT WERE TREATED BY PERCUTANEOUS SCREW FIXATION. SECOND, THEY ASSESS THE PATIENT AND INJURY CHARACTERISTICS, COMPLICATIONS, AND RETURN TO HOME RATE. ALL PATIENTS OLDER THAN 50 YEARS WHO SUFFERED A PELVIC RING FRACTURE AND WERE SURGICALLY TREATED IN THE AMSTERDAM UMC LOCATION ACADEMIC MEDICAL CENTRE (AMC) BETWEEN JANUARY 2019 AND DECEMBER 2022 WERE IDENTIFIED BY SEARCHING THE HOSPITAL¿S ELECTRONIC PATIENT FILES. 52 PATIENTS WERE INCLUDED IN THE STUDY. THE MEDIAN AGE WAS 74 YEARS OLD (IQR 62¿82, RANGE 50¿90), AND MOST PATIENTS WERE FEMALE (N=40,77%). ALL PATIENTS WERE TREATED USING EITHER ANTE- OR RETRO-GRADE PUBIC RAMI SCREWS, SI-SCREWS, FULLY TRANS SACRAL SCREWS, ILIAC SCREWS, OR ¿LC2 SCREWS¿. BOTH 7.3/6.5 (SYNTHES) FULLY AND PARTIALLY TREATED CANNULATED SCREWS OF TITANIUM AND STAINLESS STEEL WERE USED. MINIMUM FOLLOW-UP PERIOD IS 6 MONTHS POST-SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES 7.3/6.5 CANNULATED SCREWS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: CANNULATED (QTY 31): (N=10) 9 PATIENTS HAD MODERATE PAIN AND ONE HAD SEVERE PAIN. 6 PATIENTS COMPLAINED PAIN. LOCATED IN THE GROIN AREA; FIVE (10%) PATIENTS SUBSEQUENTLY HAD THEIR HARDWARE REMOVED. (N=3) LOW-GRADE INFECTION; NO TREATMENT REPORTED. (N=1) SECONDARY DISLOCATION OF THE RAMUS FRACTURE, WHICH CAUSED THE PAIN; NO TREATMENT REPORTED. (N=1) SEVERELY OSTEOPOROTIC AND SUFFERED FROM IATROGENIC FRACTURE OF THE ILIAC WING; NO TREATMENT REPORTED. (N=3) ELECTROLYTE DISORDERS; NO TREATMENT REPORTED. (N=3) DELIRIOUS EPISODES; NO TREATMENT REPORTED. (N=3) URINARY TRACT INFECTIONS; NO TREATMENT REPORTED. (N=1) ACUTE KIDNEY FAILURE; NO TREATMENT REPORTED. (N=1) DECOMPENSATED LIVER CIRRHOSIS; NO TREATMENT REPORTED. (N=1) WOUND INFECTION; NO TREATMENT REPORTED. (N=1) OSTEOMYELITIS OF THE PUBIC BONE; NO TREATMENT REPORTED. (N=1) PSEUDOANEURYSM OF THE GLUTEAL ARTERY TREATED BY THROMBIN INJECTION. (N=1) SEVERE HYPOTENSION AND ELECTROLYTE IMBALANCE CAUSED BY SIADH AND HYPERGLYCEMIA; NO TREATMENT REPORTED. (N=1) SECOND HIGH-ENERGY TRAUMA LEADING TO PELVIC RING FRACTURES WITHIN TWO MONTHS OF THE FIRST TRAUMA. AFTER THE INITIAL TRAUMA, HE HAD PERCUTANEOUS SI-SCREW FIXATION ON ONE SIDE, AND AFTER THE SECOND TRAUMA, THE NEW FRACTURES ON THE CONTRALATERAL SIDE AND BOTH RAMI WERE PERCUTANEOUSLY FIXED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: CANNULATED (QTY 9): (N=5) BACKING OUT OF THEIR PUBIC AND/OR SI-SCREW; NO TREATMENT REPORTED. (N=2) BREAKAGE OF THEIR PUBIC SCREWS (BOTH FULLY THREADED); NO TREATMENT REPORTED. (N=1) BREAKAGE OF THEIR TRANS SACRAL TRANS ILIACAL SACRAL SCREWS (TITSS); NO TREATMENT REPORTED. (N=1) LIMITED GRIP FOR THE PUBIC SCREW, WHICH CAUSED PAIN COMPLAINTS. THE PATIENT HAS OSTEOGENESIS IMPERFECTA, RESULTING IN VERY BRITTLE BONES; NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487998 UNK - SCREWS: CANNULATED: TRAUMA SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1