BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BONE STAPLE

    MDR report key: 22099406 · Received May 28, 2025

    Report

    Report Number
    8030965-2025-05345
    Event Type
    Injury
    Date Received
    May 28, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: MISTRY D, RAHMAN U, KHATRI C, CARLOS W, STEPHENS A, RIEMER B, WARD J. THE USE OF NITINOL CONTINUOUS COMPRESSION IMPLANTS IN ORTHOPAEDIC TRAUMA. INDIAN J ORTHOP. 2024 SEP 14;58(12):1861-1870. DOI: 10.1007/S43465-024-01253-W. PMID: 39664361; PMCID: PMC11628464. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DESCRIBE THE USE AND ASSOCIATED OUTCOMES OF CONTINUOUS COMPRESSION IMPLANTS (CCIS) IN MODERN DAY TRAUMA PRACTICE. BETWEEN SEPTEMBER 2019 AND MAY 2023, A TOTAL OF 60 PATIENTS UNDERGOING FRACTURE, OR TRAUMA CARE OF ANY BONE WITH 33 MALES AND 27 FEMALES WITH THE MEAN AGE OF 44.2 (8¿89) WERE TREATED WITH DEPUY SYNTHES CCIS WITH THREE SPECIFIC IMPLANTS AVAILABLE¿SPEED (81), SPEED TITAN (40), AND ELITE (1). THESE VARY BASED ON SIZE, WITH SPEED BEING THE SMALLEST (1.5 MM IN WIDTH); SPEED TITAN 3.5 MM IN WIDTH; AND THE ELITE IS THE BIGGEST (5.5 MM IN WIDTH). THE MAJORITY OF PATIENTS WHO WERE TREATED WITH CONTINUOUS COMPRESSION IMPLANTS (CCIS) WERE DONE SO FOR ACUTE FRACTURES, WITH ROUGHLY AN EVEN SPLIT OF OPEN AND CLOSED INJURIES. THREE OF THESE PATIENTS HAD CCIS USED FOR CLOSED ATYPICAL BISPHOSPHONATE FRACTURES OF THE FEMUR. THE MOST COMMON SITE FOR THE CONTINUOUS COMPRESSION IMPLANTS (CCI) WAS THE TIBIA (25 PATIENTS) FOLLOWED BY THE HUMERUS (13 PATIENTS). ALL LONG BONE PROCEDURES WERE TREATED WITH CONTINUOUS COMPRESSION IMPLANTS (CCIS) IN CONJUNCTION WITH ANOTHER METHOD OF FIXATION PROVIDING THE STABILITY. TWELVE PATIENTS HAD CCIS USED IN ISOLATION WITHOUT OTHER ORTHOPAEDIC IMPLANTS. PATIENTS MUST HAVE A MINIMUM FOLLOW-UP OF 12 MONTHS AT THE SAME CENTRE. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES CCIS. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: UNKNOWN MANUFACTURERS ARE THESE FRAME, SUTURE FIXATION, PLATE FIXATION, PLATE FIXATION + VALGUS OSTEOTOMY AND NAIL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 1): 1 MALE PATIENT HAD THEIR CONTINUOUS COMPRESSION IMPLANTS (CCI) CUT OUT FROM THEIR PATELLA SUTURE FIXATION, BUT THIS WAS SUSTAINED AFTER FURTHER TRAUMA (A FALL) 5 WEEKS AFTER THE PROCEDURE. SECONDARY PROCEDURE INCLUDE SUTURE FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 2): 1 FEMALE PATIENT HAD A MIDFOOT DISLOCATION FIXED WITH 5 CONTINUOUS COMPRESSION IMPLANTS (CCI'S) DURING THEIR INITIAL SURGERY; 2 OF THE 5 CCI'S HAD BROKEN, AND THE PATIENT HAD REMOVAL OF ALL METALWORK DUE TO PAIN 12 MONTHS AFTER THE PROCEDURE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 1): 1 MALE PATIENT HAD AN INFECTION AFTER THEIR FIXATION (INCLUDING A CCI AS AN ADJUNCT) WAS USED TO TREAT A CLOSED PERIPROSTHETIC FEMORAL FRACTURE AROUND A TOTAL KNEE ARTHROPLASTY; REQUIRED A RETURN TO THEATRE FOR REMOVAL OF METALWORK, WASHOUTS, AND REVISIONS OF FIXATIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 3): 1 MALE PATIENT HAD AN INFECTION REQUIRING A RETURN TO THEATRE FOR REMOVAL OF METALWORK, WASHOUTS, AND REVISIONS OF FIXATIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 3): 1 MALE PATIENT HAD NON-UNION 4 MONTHS AFTER THE SURGERY REQUIRING SECOND SURGERY FOR REVISION NAIL + PLATE FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 1): 1 MALE PATIENT HAD NON-UNION 8 MONTHS AFTER THE SURGERY REQUIRING SECOND SURGERY FOR FRAME. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 3): 1 MALE PATIENT HAD NON-UNION 8 MONTHS AFTER THE SURGERY; SECOND PROCEDURE WAS REVISION NAIL FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 1): 1 FEMALE PATIENT HAD A NONUNION 5 MONTHS AFTER THE SURGERY; SECOND PROCEDURE WAS REVISION PLATE FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 2): 1 FEMALE PATIENT HAD NON-UNION 5 MONTHS AFTER THE SURGERY; SECOND PROCEDURE WAS REVISION NAIL AND PLATE FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BONE STAPLE (QTY 2): 1 MALE PATIENT HAD NON-UNION 4 MONTHS AFTER THE SURGERY; SECOND PROCEDURE WAS REVISION NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875811 UNK - BONE STAPLE STAPLE, FIXATION, BONE JDR SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention