BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS

    MDR report key: 4374758 · Received December 31, 2014

    Report

    Report Number
    3003875359-2014-10441
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Report Date
    December 2, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL CODE: HRS/PLATE, FIXATION, BONE. INSTRUMENT, DEVICE NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PART WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED. 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

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THE PRODUCT DEVELOPMENT INVESTIGATION SHOWS THAT ONE OF THE FOLLOWING WAS RECEIVED: DEPTH GAUGE (PART # 03.111.005 / LOT # 3489115 / MFG LOCATION: (B)(4) / MFG. DATE: 07/2010). THE RETURNED DEPTH GAUGE WAS RECEIVED ASSEMBLED WITH THE SILVER MEASURING ROD BENT. THE DEVICE ACTUATES AS DESIGNED. A VISUAL INSPECTION, DIMENSIONAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE CAUSE OF THIS COMPLAINT CONDITION CANNOT BE DETERMINED, BUT IS MOST LIKELY DUE TO THE METHOD OF USE OR DAMAGE DURING STERILE PROCESSING WHILE IN A DISASSEMBLED STATE. THE DEVICE(S) WERE REVIEWED; RELEVANT FEATURES/DIMENSIONS WERE INSPECTED AND FOUND TO BE WITHIN SPECIFICATION. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. ALTHOUGH THE EXACT CAUSE CANNOT BE IDENTIFIED, THIS COMPLAINT CONDITION IS POSSIBLY A RESULT OF METHOD OF USE, RATHER THAN THE DESIGN OF THE INSTRUMENT. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 A PATIENT HAD A DISTAL RADIUS FRACTURE. THE SURGEON WAS USING THE DEPTH GAUGE AND THE GAUGE BEGAN TO STICK AND THE DEVICE WAS VERY HARD TO USE. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT HARM TO THE PATIENT. SURGERY WAS DELAYED 1 TO 5 MINUTES. THE SALES CONSULTANT ALSO TRIED THE GAUGE AND CONFIRMED THAT IT WOULDN¿T GLIDE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861087 DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS GUIDE FZX SYNTHES HAGENDORF 3489115

    Patients

    Seq Age Sex Outcome Treatment
    1