BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM GUIDE ROD W/STOP TROCAR TIP/230MM

    MDR report key: 6134069 · Received November 29, 2016

    Report

    Report Number
    3009450863-2016-10024
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: APR 29, 2016. 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. 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.5MM GUIDE ROD W/STOP TROCAR TIP/230MM), PART NUMBER 03.019.026, LOT NUMBER 9925171. THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE SHAFT OF THE GUIDE ROD IS SLIGHTLY BENT AND SHOWS SOME MARK AND STRIATIONS OF USE. THE TIP WAS CUT OFF DURING UNKNOWN HANDLING. THE MISSING PORTION MEASURES APPROXIMATELY 10 MM. THE COMPLAINT RELEVANT SHAFT DIAMETER WAS CHECKED AGAINST THE VALID DRAWING AND FOUND TO MEET THE SPECIFICATIONS. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS OF THE COMPLAINED DEVICE SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE GUIDE ROD Ø2.5 F/HOLLOW DRILL W/STOP L23 IS TYPICALLY USED TO OPEN MEDULLARY CANAL OF HUMERUS BONES TOGETHER WITH CORRESPONDING HOLLOW DRILL BITS. THE MANNER OF DAMAGE AND SHEARED OFF GUIDE ROD SHAFT SHOWS THAT THE DEVICE WAS SUBJECTED TO MECHANICAL SIDE OVERLOADING WHILE REAMING. NO PRODUCT FAULT COULD BE DETECTED. IT WAS CONCLUDED THAT THE ROOT CAUSE IS EXCESSIVE FORCE THROUGH THE METHOD OF USE AND ASSOCIATED ACCUMULATED DAMAGE AND WEAR. 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.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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE 2.5MM GUIDE ROD WAS USED AS A GUIDE BEFORE THE HOLLOW REAMER WAS INSERTED. AFTER THE HOLLOW REAMER WAS USED A FRAGMENT WAS NOTICED IN THE MEDULLARY CANAL. THE GUIDE ROD WAS THEN REMOVED. ONLY THEN DID THE SURGICAL TEAM REALIZE THAT THE GUIDE ROD WAS DAMAGED AND THE FRAGMENT INSIDE THE PATIENT WAS FROM THE GUIDE ROD. THE FRAGMENT WAS LEFT INSIDE THE PATIENT AS IT WAS TOO DEEP INTO THE MEDULLARY CANAL AND COULD NOT BE RETRIEVED WITHOUT FURTHER TRAUMATIZING THE PATIENT. NO ADDITIONAL PATIENT HARM WAS REPORTED. THERE WAS NO PROLONGATION OF THE SURGERY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: HOLLOW REAMER (PART/LOT UNKNOWN, QUANTITY 1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784430 2.5MM GUIDE ROD W/STOP TROCAR TIP/230MM GUIDE FZX SYNTHES BALSTHAL 9925171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention