BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 10227467 · Received July 2, 2020

    Report

    Report Number
    8030965-2020-04628
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Report Date
    June 25, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWE
    UDI-DI
    07611819018631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. 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

    INVESTIGATION SUMMARY: BACKGROUND. EQUIPMENT: 41019674. DRILL BIT 2.0 WITH DOUBLE MARKS REF: 323.062, IT WAS BROKEN IN HALF. DRILL 1.8 L100 / 75 REF: 310.510 THE TIP WAS BROKEN. FROM EQUIPMENT WHERE 3.5 ELBOW AV SYSTEM IS LOCATED (SORRY I DID NOT WRITE DOWN EQUIPMENT NUMBER). DRILL 2.5 MM L100 / 85 REF: 310.250, THE ENTIRE TIP REMAINED. I ATTACHED THE PICTURES OF HOW THE PRODUCTS WERE PACKED IN THEIR RESPECTIVE VARIOUS CASES. I APPRECIATE THE ATTENTION GIVEN AND I WILL BE ATTENTIVE TO ANY SUGGESTION. CODE: 323.062; LOT: NOT INFORMED. CODE: 310.510; BATCH: L100 / 75. CODE: 310,250; BATCH: L100 / 85. THIS COMPLAINT INVOLVES THREE (3) DEVICES. CUSTOMER QUALITY INVESTIGATION: THE DRILL BIT Ø2.5 L110/85 2FLUTE (PART # 310.250/ LOT UNK) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE FROM THE ATTACHMENTS (¿SOURCE FILE - NOVEDAD DE SERVICIO CL REINA SOFIA¿ IN THE NOTES & ATTACHMENTS SECTION OF THE PRODUCT COMPLAINT). THE IMAGES WERE REVIEWED, AND IT WAS OBSERVED THAT THE TIP OF BIT WAS BROKEN. THE GEOMETRY OF THE TIP WAS NOT CONSISTENT WITH A COMPLETE BIT. THE BROKEN FRAGMENT WAS NOT PICTURED. AS THE BIT WAS NOT RETURNED AN AS RECEIVED, DIMENSIONAL, AND MATERIAL REVIEW WERE NOT APPLICABLE. MANUFACTURING RECORD EVALUATION: A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE PROVIDED IMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS) (B)(4). CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED AS THE DRILL BIT WAS PICTURED BROKEN. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL PROCODE: GFF, GFA, HSZ. REPORTER IS A J&J EMPLOYEE. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, A 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BROKE. THE 1.8MM DRILL BIT/QC/100MM WAS ALSO FOUND TO HAVE A BROKEN TIP. THE TIP ON THE 2.5MM DRILL BIT/QC/GOLD/110MM REMAINED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691457 2.5MM DRILL BIT/QC/GOLD/110MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE OBERDORF SYNTHES PRODUKTIONS GMBH 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BIT Ø1.8 L100/75 2FLUTE| DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3