BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER FOR TI ELASTIC NAILS

    MDR report key: 10072551 · Received May 19, 2020

    Report

    Report Number
    8030965-2020-03596
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTZ
    UDI-DI
    07611819096646
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H6: ONLY THE FOLLOWING SUBCOMPONENTS WERE SENT BACK FOR INVESTIGATION, HENCE, THE CORRECT LOT NUMBER OF THE TOP LEVEL PART 359.217 COULD NOT BE IDENTIFIED. SCHLUESSELKOERPER KPL. (ARTICLE 50136517; PRODUCT CODE 359.217.004) , DOUBLEHEX SW11 (ARTICLE 50101971; PRODUCT CODE 321.200.002). VISUAL INSPECTION VISUAL INSPECTION CONFIMED THAT THE COMPONENT PART 321.200.002 IS DAMAGED, THERE ARE TWO CHIPS BROKEN OFF. DIMENSIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWINGS WERE REVIEWED DURING THE INVESTIGATION (CURRENT VERSION): CUTTER FOR TI ELASTIC NAILS (359.217) HANDLE FOR CUTTER 359.217 TEN (359.217.004) DOUBLEHEX SW11 (321.200.002) DISASSEMBLY/ASSEMBLY INSTRUCTION, PART 359.217.004 CAN BE DISASSEMBLED FOR REPROCESSING REASONS. SPARE PARTS: PART# 321.200.002 AND 359.217.004 ARE NOT AVAILABLE AS SPARE PARTS. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE COMPONENT PART 321.200.002 IS DAMAGED; THERE ARE TWO CHIPS BROKEN OFF. THIS DOUBLEHEX SW11 IS ETCHED WITH LOT# 1010 INDICATING THAT THIS PART IS MORE THAN 15 YEARS OLD. THE REVIEW OF THE PRODUCTION HISTORY COULD NOT BE PERFORMED DUE TO MISSING INFORMATION, ONLY THE TWO COMPONENT PARTS WERE RETURNED FOR INVESTIGATION, HENCE, THE CORRECT LOT NUMBER OF THE TOP LEVEL PART 359.217 COULD NOT BE IDENTIFIED. HOWEVER, CONSIDERING THE AGE OF THE DAMAGED COMPONENT PART A WEAR OR USE RELATED ROOT CAUSE IS THE MOST LIKELY REASON OF THE COMPLAINED MALFUNCTION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 1

    ADDITIONAL NARRATIVE: (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE DURING THE CLEANING/STERILIZATION A CHIP WAS FOUND OFF. THE SURGERY OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536253 CUTTER FOR TI ELASTIC NAILS INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ OBERDORF SYNTHES PRODUKTIONS GMBH 07611819096646

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER F/TEN| CUTTER F/TEN