BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM DRILL GUIDE

    MDR report key: 4863280 · Received June 23, 2015

    Report

    Report Number
    3003787298-2015-10036
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 11, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW ¿ DRILL GUIDE (2.4MM), LOT # 6102791 CORRESPONDING TO PART # 03.507.005 WAS PURCHASED TO (B)(4). ON (B)(4) 2009, THE INSPECTION WAS CONDUCTED AT SYNTHES ON (B)(4) 2009, OBTAINING ACCEPTABLE RESULTS. NO MRR INVESTIGATIONS WERE REPORTED DURING THE INSPECTION PROCESS OF THESE PARTS. SUPPLIER CERTIFICATE OF COMPLIANCE DATED ON (B)(4) 2009 INDICATED THAT SUBJECT PART NUMBER WAS MANUFACTURED IN ACCORDANCE TO THE MATERIAL AND ALL CUSTOMER SPECIFICATIONS NOTED ON THE PRODUCT DRAWING AND PURCHASE ORDER. THIS MATERIAL WAS RELEASED TO WAREHOUSE ON 02-JUNE-2009. NO INVESTIGATIONS WERE REPORTED DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED WITH THE ISSUE EXPLAINED IN THIS COMPLAINT. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 03.507.005, 2.4MM DRILL GUIDE, LOT NUMBER 6102791). THE SUBJECT DEVICE WAS RETURNED WITH THE REPORTED CONDITION OF ¿TIP FOUND BROKEN AFTER STERILE PROCESSING.¿ THIS CONDITION IS CONFIRMED; THE DRILL GUIDE IS MISSING APPROXIMATELY EIGHT MILLIMETERS OF THE MOST DISTAL PORTION OF THE DEVICE. IT IS LIKELY THAT ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING IN CONJUNCTION WITH OVER SIX YEARS OF USE HAS LED TO THIS COMPLAINT CONDITION; HOWEVER, A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE WAS MANUFACTURED IN 6/2009 AND IS OVER SIX YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH NUMEROUS MARKINGS ALONG THE BARREL DRILL GUIDE PORTION OF THE DEVICE. THE ASSOCIATED DEVICE DRAWING WAS REVIEWED AND IT WAS DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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: 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

    IT WAS REPORTED THAT THE TIP OF A DRILL GUIDE WAS FOUND BROKEN INSIDE A SET AFTER GOING THROUGH STERILE PROCESSING. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407411 2.4MM DRILL GUIDE GUIDE FZX SYNTHES BRANDYWINE 6102791

    Patients

    Seq Age Sex Outcome Treatment
    1