BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5004624 · Received August 14, 2015

    Report

    Report Number
    2530088-2015-10540
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE WAS ORIGINALLY REPORTED AS BEING BETWEEN 16-25 YEARS OLD. PATIENT AGE (AND AGE RANGE) ARE UNKNOWN. DEVICE 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

    PRODUCT INVESTIGATION SUMMARY: THE DEPTH GAUGE (319.006 / LOT 4070014) WAS RETURNED WITH THE COMPLAINT DESCRIPTION: ¿¿THE DEPTH GAUGE IS NOT SLIDING EASILY. IT IS GETTING STUCK, MAKING IT DIFFICULT TO GET AN ACCURATE SCREW LENGTH READING.¿ THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED AS THE DEPTH GAUGE FUNCTIONED AS INTENDED AND OPERATED SMOOTHLY. THE COMPLIANT IS UNCONFIRMED. AS NO PRODUCT FAULTS WERE FOUND WITH THE RETURNED IMPLANT, NO FURTHER INVESTIGATION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO ROOT CAUSE WAS ABLE TO BE DETERMINED AS NO PRODUCT FAULTS WERE FOUND WITH THE RETURNED IMPLANT. DEVICE 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: PATIENT ID AND WEIGHT ARE UNKNOWN. PATIENT AGE REPORTED AS BETWEEN 16 AND 25 YEARS OLD. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MANUFACTURING LOCATION: (B)(4) ASSEMBLY. MANUFACTURING DATE: 22 FEBRUARY 2000. PART: 319.006, LOT : 4070014 (NON-STERILE) - DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. LOT WAS RELEASE TO THE WAREHOUSE ON 22 FEBRUARY 2000. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    UPDATE: IT WAS CONFIRMED THAT PLATE BENDERS WERE NOT USED DURING THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEPTH GAUGE IS NOT SLIDING EASILY DURING AN OLECRANON PROCEDURE. IT IS GETTING STUCK, MAKING IT DIFFICULT TO GET AN ACCURATE SCREW LENGTH READING. IT WAS SOAKED IN WATER TO HELP IT SLIDE BUT THAT DID NOT WORK. PLATE BENDERS FROM ANOTHER SET WERE USED. THIS WAS NOT A REVISION PROCEDURE. ANOTHER PART WAS AVAILABLE TO COMPLETE THE SURGERY AND THERE WAS NO DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538546 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 4070014

    Patients

    Seq Age Sex Outcome Treatment
    1