BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE / Ø 4.2MM

    MDR report key: 22641928 · Received July 29, 2025

    Report

    Report Number
    8030965-2025-07642
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982296139
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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. H11 ADDITIONAL NARRATIVE: ADDED: H4. CORRECTED: G1. DEVICE HISTORY REVIEW: PART NUMBER: 03.045.020-US. LOT NUMBER: 5916P56. MANUFACTURING SITE: HAEGENDORF. RELEASE TO WAREHOUSE DATE:22-JUN-2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. FINISHED DEVICE LOT NUMBER IS PART OF CAPA JBL-CAPA-000388, HOWEVER, THIS CAPA IS NOT RELATED TO THE DENT, BUT TO THE APPLICATION OF SECONDARY PASSIVATION PROCESS USING CITRIC ACID INSTEAD OF NITRIC ACID WHICH IS APPROVED AS USE-AS-IS AND DOCUMENTED ACCORDINGLY IN JBL-NR / JNJ-NR-0199988. 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 THE DEVICES WERE DENTED INWARD AT THE TIPS, MAKING THE HOLE SMALLER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333627 DRILL SLEEVE / Ø 4.2MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 5916P56 10886982296139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown