BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL

    MDR report key: 19657622 · Received July 2, 2024

    Report

    Report Number
    8030965-2024-08203
    Event Type
    Injury
    Date Received
    July 2, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    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. H11 ADDITIONAL NARRATIVE: 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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: KANG Y, ZHANG Q, MA Y, ZHOU M, JIA X, LIN F, WU Y, RUI Y. CLINICAL EFFECT OF NICE KNOT-ASSISTED MINIMALLY INVASIVE TITANIUM ELASTIC NAIL FIXATION TO TREAT ROBINSON 2B MIDSHAFT CLAVICULAR FRACTURE. BMC MUSCULOSKELET DISORD. 2024 JAN 13;25(1):59. DOI: 10.1186/S12891-024-07197-4. PMID: 38216916; PMCID: PMC10787378. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO PRESENT A SURGICAL METHOD¿NICE KNOT-ASSISTED TEN FIXATION¿FOR TREATING ROBINSON 2B MIDSHAFT CLAVICULAR FRACTURES. FROM JANUARY 2016 TO APRIL 2020, 29 PATIENTS WITH ROBINSON 2B MIDSHAFT CLAVICULAR FRACTURES WERE TREATED USING NICE KNOT-ASSISTED MINIMALLY INVASIVE TEN FIXATION AT THE SAME HOSPITAL. OF THESE, 14 PATIENTS WERE MALE, AND 15 PATIENTS WERE FEMALE, AND THEIR AGES RANGED FROM 17 TO 63 YEARS. OF THE 29 PATIENTS, 17 SUSTAINED ¿SIMPLE¿ DISPLACED TWO-PART MIDSHAFT CLAVICLE FRACTURES (ROBINSON 2B.1), AND THE REMAINING 12 PATIENTS SUSTAINED DISPLACED ¿COMPLEX MULTI FRAGMENTARY¿ CLAVICLE FRACTURES, COMPRISING THREE-PART AND FOUR-PART FRACTURES. ALL PATIENTS UNDERWENT INTRAMEDULLARY FIXATION USING 2.0 TO 3.0 MM TITANIUM ELASTIC NAIL (SYNTHES). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL (QTY.6). - 20-YEAR-OLD MALE PATIENT HAD HYPERTROPHIC NONUNION REQUIRING NAIL REMOVAL - 49-YEAR-OLD FEMALE PATIENT HAD A LOCAL PROTRUSION OF THE TAIL OF THE ELASTIC NAIL AFTER SURGERY, IRRITATING THE SKIN REQUIRING NAIL CUT OFF. - 63-YEAR-OLD FEMALE PATIENT HAD IMPLANT IRRITATION HAD LOCAL PROTRUSION OF THE TAIL OF THE ELASTIC NAIL AFTER SURGERY, IRRITATING THE SKIN REQUIRING NAIL CUT OFF. - 41-YEAR-OLD FEMALE PATIENT HAD AFFECTED SLEEP WITH NO INTERVENTION REPORTED. - 55-YEAR-OLD MALE PATIENT HAD IMPLANT IRRITATION HAD LOCAL PROTRUSION OF THE TAIL OF THE ELASTIC NAIL AFTER SURGERY, IRRITATING THE SKIN REQUIRING NAIL CUT OFF. - 47-YEAR-OLD MALE PATIENT HAD IMPLANT IRRITATION HAD LOCAL PROTRUSION OF THE TAIL OF THE ELASTIC NAIL AFTER SURGERY, IRRITATING THE SKIN REQUIRING NAIL CUT OFF. THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756635 UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention