BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR

    MDR report key: 18378255 · Received December 21, 2023

    Report

    Report Number
    8030965-2023-16013
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    October 2, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    UDI-DI
    07611819342873
    PMA / PMN Number
    K170818
    Product Problem
    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. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODE: PBJ. H3, H4, H6 THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR WAS FOUND BROKEN AT THE TIP, FRAGMENT WAS RECEIVED, NO OTHER ISSUES WERE OBSERVED. A DIMENSIONAL INSPECTION FOR THE EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED. THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: -REMOVABLE EXTENSION, FLEXIBLE CRANIOFACIAL DISTRACTOR 04_315_125_SUSA REV. F (CURRENT AND MANUFACTURED). DIMENSIONAL INSPECTION: N/A. H4, H6. 12/13/2023 BY: C. WILLIAM SCHUBELE. PART NUMBER: 04.315.125-US. LOT NUMBER: 527P580. PART MANUFACTURE DATE: 10/20/2022. MANUFACTURING LOCATION: BRANDYWINE. PART EXPIRATION DATE: N/A. NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD OF THIS LOT REVEALED NO COMPLAINT-RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THAT THE REMOVABLE EXTENSIONS WERE PROCESSED THROUGH ALL OPERATIONS OF THE RELEASED ROUTING AND HAD MET ALL SPECIFICATION CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT ON OCTOBER 02,2023. THERE IS A INCIDENT THERE MANDIBLE DISTRACTOR CASE WITH A CMF EXTRACTION SET 30MM FLEXIBLE EXTENSION ARM PART NUMBER 04.315.125 THAT WAS MALFUNCTION AND HAPPENED FOR FOUR OF THE DEVICES IN THAT TRAY. ISSUE OCCURRED DURING SURGERY BUT NO DIRECT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035269 EXTENSARM REMOVABLE FLEX L30 F/CMF DISTR EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN SYNTHES GMBH 527P580 07611819342873

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DA Unknown