BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA

    MDR report key: 18866602 · Received March 8, 2024

    Report

    Report Number
    8030965-2024-03413
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 16, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D2: ADDITIONAL PROCODE: NBH. H6: COMPONENT CODE: G07002 DEVICE NOT RETURNED. H6: PART: 314.743. SYNTHES LOT: 7061004. SUPPLIER LOT: 7061004. RELEASE TO WAREHOUSE DATE: 03 APRIL 2013. SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. 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.

    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. H10 ADDITIONAL NARRATIVE: E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT BONE TRANSPLANTING FOR FEMORAL FRACTURE WITH NONUNION. A DRIVESHAFT WAS BEING OPERATED, A LOCKING CLIP CAME OFF. THE DRIVESHAFT WAS PERFORMED WHILE IT WAS BEING HELD BY HAND. WHILE A GRAFT FILTER WAS WORKING FOR ABSORPTION AND COLLECTION, MORE THAN 4 PIECE OF METAL FRACTIONS WERE DISCOVERED INSIDE OF THE GRAFT FILTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS ASSUMED THAT THE APPROACH OF HOLD FOR A GRAFT FILTER BY HAND WAS OUT OF REGULAR APPROACH, SO A CONNECTION FUNCTION WORKED UNWELL, AND ITSELF DID NOT LAST EFFECTIVE, AND THUS SUCH SITUATION TRIGGERED THE DRIVESHAFT¿S TIP MIGHT HAVE BEEN BROKEN OFF. NO DAMAGED REAMER PORTION WAS CONFIRMED. UNDER IMAGE INTENSIFIER¿S OBSERVATION, NO METAL FRACTION IN MEDULLARY CAVITY WAS CONFIRMED. PLUS, THERE WAS CONFIRMED NO REMAINS IN PATIENTS¿ BODY THROUGH POSTOPERATIVE X-RAY PHOTOS. THIS REPORT IS FOR DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881312 DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA REAMER HTO SYNTHES GMBH 7061004 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown