BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5050706 · Received September 2, 2015

    Report

    Report Number
    2530088-2015-10577
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 21, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS 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

    SERVICE HISTORY REVIEW: PART NUMBER: 319.006, LOT NUMBER: 6083723: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 13FEBRUARY2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINT CONDITION FOR THE 319.006 LOT NUMBER 6083723 DEPTH GAUGE WAS LIKELY CAUSED BY ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. PER THE TECHNIQUE GUIDE, THE 319.006 DEPTH GAUGE IS AN INSTRUMENT ROUTINELY USED IN THE 2.4MM LCP DISTAL RADIUS SYSTEM. THE DEVICE WAS RETURNED AND REPORTED THAT THE MEASURING NEEDLE WAS FOUND DAMAGED. THIS CONDITION IS CONFIRMED; THE MEASURING NEEDLE IS LOOSE AND WIGGLES NEAR THE BASE OF THE DEVICE. IT IS LIKELY THAT ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN FEBRUARY 2009 AND IS OVER SIX YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY GOOD CONDITION WITH ONLY A FEW MARKINGS AND SIGNS OF WEAR. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. THE RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. IT IS LIKELY THAT ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED 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

    (B)(4) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE MEASURING NEEDLE WAS DISCOVERED DAMAGED AND/OR MISSING A PART BY THE STERILE PROCESSING DEPARTMENT. THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580770 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 6083723

    Patients

    Seq Age Sex Outcome Treatment
    1