BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS

    MDR report key: 20313939 · Received September 26, 2024

    Report

    Report Number
    8030965-2024-12231
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 12, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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

    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. H11 ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KASPER AA, REDDY Y, PLUSCH K, ADAMS A, BEREDJIKLIAN PK, KACHOOEI AR. NONUNION AFTER USING PROCEDURE-SPECIFIC INSTRUMENTATIONS FOR ULNAR SHORTENING OSTEOTOMY. ARCH BONE JT SURG. 2023;11(11):677-683. DOI: 10.22038/ABJS.2023.73837.3418. PMID: 38058964; PMCID: PMC10697189. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY PURPOSE OF THIS STUDY WAS TO COMPARE THE RATES OF NONUNION AMONG DIFFERENT OSTEOTOMY DESIGNS (COMPANY BRAND) AND THE RATES OF NONUNION BETWEEN OBLIQUE AND TRANSVERSE OSTEOTOMIES. A RETROSPECTIVE COHORT STUDY OF PATIENTS UNDERGOING ULNAR SHORTENING OSTEOTOMY FROM OCTOBER 2015 TO FEBRUARY 2022 IN A SINGLE INSTITUTE, INCLUDING 17 HAND FELLOWSHIP-TRAINED PROVIDERS. A FINAL COHORT OF 92 PATIENTS WHO MET THE INCLUSION AND EXCLUSION CRITERIA WAS INCLUDED IN THIS STUDY. 92 PATIENTS WEWRE INCLUDED IN THIS STUDY WITH A MEAN AGE OF 48 YEARS (SD=15), INCLUDING 58 FEMALES AND 34 MALES. OF THE 92 PATIENTS, 83 (90%) HAD A BONE UNION, WITH AN AVERAGE TIME TO THE UNION BEING 83 DAYS (RANGE 20-494 DAYS). ALL PATIENTS HAD A MINIMUM OF FOUR MONTHS FOLLOW-UP AFTER SURGERY. TOTAL NUMBER OF 92 PATIENTS INCLUDED APTUS (MEDARTIS, BASEL, SWITZERLAND) (N=22), TRIMED(SANTA CLARITA, CALIFORNIA, USA) (N=22), SYNTHES (DEPUYSYNTHES, SWITZERLAND) (N=17), RAYHACK (WRIGHT MEDICAL, MEMPHIS, TENNESSEE, USA (N=18), SKELETAL DYNAMICS(MIAMI, FLORIDA, USA) (N=3), AND ACUMED (HILLSBORO, OREGON, USA) (N=2). IN EIGHT PATIENTS, OSTEOTOMY WAS MADE FREEHAND AND WAS FIXED USING A CONVENTIONAL SYNTHES LCDCP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ULNA OSTEOTOMY SYSTEM AND DEPUY SYNTHES LC-DCP ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS (QTY 1) (N=1) A 60 YEARS OLD, MALE HAD NONUNION NO INTERVENTION WAS PERFORMED AS THE PATIENT WAS ASYMPTOMATIC. (N=1) A 46 YEARS OLD, FEMALE HAD NONUNION NO INTERVENTION WAS PERFORMED AS THE PATIENT WAS ASYMPTOMATIC. (N=1) A 59 YEARS OLD, FEMAL HAD NONUNION NO INTERVENTION WAS PERFORMED AS THE PATIENT WAS ASYMPTOMATIC. (N=1) A 21 YEARS OLD, MALE WITH HARDWARE IRRITAION UNDERWENT HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LC-DCP PLATE/SCREWS (QTY 1) (N=1) A 50 YEARS OLD, FEMALE HAD NONUNION NO INTERVENTION WAS PERFORMED AS THE PATIENT WAS ASYMPTOMATIC. (N=1) A 63 YEARS OLD, FEMALE HAD NONUNIO AND UNDERWENT REVISION SURGERY. (N= 1) A 33 YEARS OLD, MALE WITH HARDWARE IRRITATION UNDERWENT HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491729 UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention