BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE

    MDR report key: 8237413 · Received January 10, 2019

    Report

    Report Number
    2939274-2019-55780
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    December 2, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982071804
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.110.000, LOT: 9230272. MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: DEC 12, 2014. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: PRODUCT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION REVEALED NO ISSUES WITH INSTRUMENT. NO DAMAGE WAS NOTED ON THE DEVICE. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE DRILL BIT WAS NOT RETURNED AND THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED WITHOUT IT. MEASURED DIMENSIONS CONFORM TO SPECIFICATION. THE RELEVANT DRAWINGS WERE REVIEWED; BASED ON THE VISUAL INSPECTION AND DIMENSIONAL INSPECTION THE COMPLAINT IS UNCONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED AS NO ISSUES WERE FOUND WITH THE GUIDE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H11 CORRECTED DATA: B4, G4: THESE DATES WERE INADVERTENTLY REPORTED AS 12/14/2018 IN THE INITIAL REPORT. THE CORRECT DATE IS 12/02/2018. 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 ON DECEMBER 2, 2018, DURING INVENTORY OF DISTAL RADIUS SET AT SANTA ANA METRO OFFICE IT WAS NOTICED THAT THE UNKNOWN VARIABLE ANGLE DRILL GUIDE WASN'T ALLOWING THE UNKNOWN DRILL BIT TO PASS SMOOTHLY THROUGH THE INSTRUMENT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, THE VARIABLE ANGLE LOCKING DRILL GUIDE DID NOT ALLOW THE UNKNOWN DRILL BIT TO PASS SMOOTHLY THROUGH THE INSTRUMENT DURING INVENTORY OF A DISTAL RADIUS SET. THE EVENT OCCURRED AT THE SANTA ANA METRO OFFICE. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29315 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9230272 10886982071804

    Patients

    Seq Age Sex Outcome Treatment
    1