BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 23262108 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00003
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    July 3, 2024
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT SUMMARY: A HOSPITAL REPRESENTATIVE REPORTED THE FAILURE OF SIX FRT240-HEX UNITS. THREE UNITS BROKE INSIDE THE PATIENT, AND THREE UNITS BROKE DURING ASSEMBLY. THESE ISSUES LED TO AN ADDITIONAL OSTEOTOMY AND CAUSED A SURGERY DELAY, ALTHOUGH THE EXACT DURATION ATTRIBUTABLE TO THE FRT240 FAILURES WAS NOT SPECIFIED. THE PRIMARY REASON FOR THE SURGERY WAS A BROKEN BONE, WHICH ALSO CAUSED THE IMPLANT INSIDE THE BONE TO BEND. THE HOSPITAL REPRESENTATIVE INDICATED THAT THIS WAS A SPECIAL CASE AS THE IMPLANT WAS DEEPLY EMBEDDED INSIDE THE BONE. BREAKAGE INSIDE THE PATIENT: THE FIRST THREE FRT240-HEX UNITS BROKE INSIDE THE PATIENT DUE TO THE SURGEON'S INABILITY TO FULLY ENGAGE THE FEMALE RETRIEVER HEX INTO THE IMPLANT HEAD. THIS DIFFICULTY AROSE BECAUSE THE IMPLANT WAS DEEPLY EMBEDDED IN THE BONE. SMALLER TREPHINES WERE USED TO CLEAR THE SPACE ABOVE THE IMPLANT HEAD. HOWEVER, THE NARROWNESS OF THE BONE MADE IT IMPOSSIBLE TO USE A LARGER TREPHINE, WHICH WOULD HAVE PROVIDED ENOUGH SPACE FOR EASIER REMOVAL OF THE IMPLANT. CONSEQUENTLY, A SIGNIFICANT AMOUNT OF BLOOD, BONE DEBRIS, AND TISSUE ACCUMULATED INSIDE AND AROUND THE IMPLANT HEAD, REQUIRING HIGH PULL-OUT FORCES FOR RETRIEVAL. THESE CONDITIONS MADE IT CHALLENGING TO PROPERLY ENGAGE THE RETRIEVAL TOOL AND EXTRACT THE IMPLANT, LEADING TO SLIPPAGE, INADEQUATE DEPLOYMENT OF THE INSTRUMENT, AND ULTIMATELY, THE BREAKAGE OF THE UNITS. NO BROKEN PIECES OF THE INSTRUMENT REMAINED IN THE PATIENT. BREAKAGE DURING ASSEMBLY: THE SUBSEQUENT THREE BREAKAGES OCCURRED DURING THE ASSEMBLY PROCESS. THESE FAILURES WERE ATTRIBUTED TO IMPROPER ASSEMBLY TECHNIQUES AND EXCESSIVE PRE-EXPANSION OF THE FEMALE RETRIEVER OUTSIDE THE IMPLANT. THIS IMPROPER HANDLING AND PRE-EXPANSION CONTRIBUTED TO THE STRUCTURAL FAILURE OF THE UNITS. CONCLUSION: IN SUMMARY, SIX FRT240-HEX UNITS FAILED - THREE DURING SURGERY AND THREE DURING ASSEMBLY - RESULTING IN ADDITIONAL OSTEOTOMY AND SURGERY DELAYS. THE BREAKAGES INSIDE THE PATIENT WERE DUE TO THE PATIENT CONDITION. THE ASSEMBLY BREAKAGES WERE CAUSED BY IMPROPER ASSEMBLY TECHNIQUES AND EXCESSIVE PRE-EXPANSION. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED ON (B)(6) 2024 BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    A HOSPITAL REPRESENTATIVE REPORTED THE FAILURE OF SIX FRT240-HEX UNITS. THREE UNITS BROKE INSIDE THE PATIENT, AND THREE UNITS BROKE DURING ASSEMBLY. THESE ISSUES LED TO AN ADDITIONAL OSTEOTOMY AND CAUSED A SURGERY DELAY, ALTHOUGH THE EXACT DURATION ATTRIBUTABLE TO THE FRT240 FAILURES WAS NOT SPECIFIED. THE PRIMARY REASON FOR THE SURGERY WAS A BROKEN BONE, WHICH ALSO CAUSED THE IMPLANT INSIDE THE BONE TO BEND. THE HOSPITAL REPRESENTATIVE INDICATED THAT THIS WAS A SPECIAL CASE AS THE IMPLANT WAS DEEPLY EMBEDDED INSIDE THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029655 THE FASSIER-DUVAL TELESCOPIC IM SYSTEM 3.2 CARTRIDGE LXH PEGA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other