BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL

    MDR report key: 19679090 · Received July 5, 2024

    Report

    Report Number
    8030965-2024-08268
    Event Type
    Injury
    Date Received
    July 5, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. D1, D2A, D2B, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: TITANIUM ELASTIC NAIL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: LU Y, CANAVESE F, LIN R, CHEN J, CHEN Y, HUANG Y, CHEN S. ELASTIC STABLE INTRAMEDULLARY NAILING AND TEMPORARY EXTERNAL FIXATION FOR THE TREATMENT OF UNSTABLE FEMORAL SHAFT FRACTURES IN CHILDREN AGED 5-11 YEARS OLD: A RETROSPECTIVE STUDY OF 28 CASES. FRONT PEDIATR. 2022 JUN 30; 10:914834. DOI: 10.3389/FPED.2022.914834. PMID: 35844755; PMCID: PMC9279610. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF UFSF IN CHILDREN AGED 5 TO 11 YEARS MANAGED BY THE COMBINED USE OF ESIN AND EF. BETWEEN MARCH 2016 TO APRIL 2020, A TOTAL OF A TOTAL OF (B)(4) PEDIATRIC PATIENTS WITH FEMORAL SHAFT FRACTURES WERE ADMITTED TO OUR INSTITUTION DURING THE STUDY PERIOD. HOWEVER, 28 OUT OF 289 PATIENTS MET THE INCLUSION CRITERIA AND WERE ANALYZED IN THIS STUDY. THERE WERE 18 BOYS AND 10 GIRLS WITH MEAN AGE 5 TO 11 YEARS. ALL SURGERIES WERE PERFORMED BY THE SAME EXPERIENCED PEDIATRIC ORTHOPEDIC SURGEON (S.C.). TWO C-SHAPED TITANIUM ELASTIC NAILS (TEN; SYNTHES, SOLOTHURN, SWITZERLAND) WERE INSERTED RETROGRADE WHEN THE FRACTURE SITE WAS IN THE PROXIMAL AND MIDDLE THIRD OF THE FEMUR; ONE C- AND ONE S-SHAPED ELASTIC NAIL WERE INSERTED ANTEROGRADE WHEN THE FRACTURE WAS IN THE DISTAL THIRD. ONCE THE TWO ELASTIC NAILS WERE INSERTED, HOFFMANN-II EF (SK-EXTERNAL FIXATORS, DOUBLE, XIAMEN, CHINA) WAS APPLIED TO ACHIEVE THE FINAL REDUCTION AND TO CONTROL THE LENGTH AND ROTATION OF THE FRACTURED BONE. MEAN FOLLOW UP WAS 12 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES TITANIUM ELASTIC NAIL OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: HOFFMANN-II EF (SK-EXTERNAL FIXATORS). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN SYNTHES TITANIUM ELASTIC NAIL (1 QTY ) - A 11-YEAR-OLD MALE HAD A LOWER LIMB DISCREPANCY OF 13 MM AT THE LAST FOLLOW-UP VISIT. NO TREATMENT WAS DONE. THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133843 UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention