BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION DEVICE FOR SUPRAPATELLAR

    MDR report key: 7874052 · Received September 13, 2018

    Report

    Report Number
    8030965-2018-56323
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    July 25, 2018
    Report Date
    July 26, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWN
    UDI-DI
    07611819501782
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART: 03.010.443; SYNTHES LOT: T140927; RELEASE TO WAREHOUSE DATE: SEPTEMBER 23, 2016; MANUFACTURE SITE: (B)(4); PART EXPIRATION DATE: N/A; LIST OF NONCONFORMANCES: N/A. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. INVESTIGATION SITE: (B)(4); SELECTED FLOW: 2. DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: THE COMPRESSION TOOL IS COMPLETELY SCREWED INTO THE CONNECTING SCREW. THERE ARE WEAR MARKS AT THE HEXAGON AND AT THE END SURFACE AT THE FOREFRONT VISIBLE. FUNCTION TEST: THE DEVICES ARE COMPLETELY JAMMED, AND A SEPARATION IS IMPOSSIBLE. THEREFORE, A FUNCTION TEST OF THE INDIVIDUAL PARTS IS NOT POSSIBLE. NEVERTHELESS, BOTH DEVICES WERE ASSEMBLED WITH AN AVAILABLE INSERTION HANDLE, PART 03.010.440 AND AN EXPERT TIBIAL NAIL, PART 04.004.346. THE JAMMED DEVICES COULD BE ASSEMBLED WITH THE MATING PARTS WITHOUT ANY ISSUES. DIMENSIONAL INSPECTION: THE DEVICES ARE JAMMED, THEREFORE ONLY THE SHAFT DIAMETER OF THE COMPRESSION TOOL COULD BE CHECKED DURING THE INVESTIGATION. CHECKED DIMENSIONS WITH CALIPER PER DRAWING: SHAFT DIAMETER: SPECIFICATION 4.2MM +/-0.1 / MEASURED: 4.21MM = PASS ALSO THE INSERTION DEPTH WAS CHECKED WITH THE AVAILABLE INSERTION HANDLE, THE MEASURED DEPTH OF THE JAMMED COMPRESSION TOOL WAS FROM THE HANDLE/NAIL INTERFACE 43.15MM. DRAWING/SPECIFICATION REVIEW: THE EXPERT TIBIA NAIL DRAWING WAS REVIEWED TO DEFINE THE INSERTION DEPTH OF THE COMPRESSION TOOL. CONSIDERING THE DIAMETER OF 4MM FROM THE REQUIRED LOCKING SCREW THE MAXIMUM INSERTION DEPTH OF THE TOOL WOULD BE 41MM. THE SUPRAPATELLAR INSTRUMENTATION FOR EXPERT TIBIAL NAIL SURGICAL TECHNIQUE WAS REVIEWED AND FOLLOWING RELEVANT STATEMENTS FOR INSERT COMPRESSION DEVICE WERE FOUND: ¿CONFIRM THAT THE NAIL IS SECURELY CONNECTED TO THE INSERTION HANDLE USING THE SCREWDRIVER. INSERT THE COMPRESSION DEVICE THROUGH THE CONNECTING SCREW AND INTO THE NAIL USING THE SCREWDRIVER. THE COMPRESSION DEVICE WILL CONTACT THE DYNAMIC LOCKING SCREW. PRECAUTION: DO NOT OVERTIGHTEN THE COMPRESSION DEVICE, IT MAY DEFORM THE LOCKING SCREW.¿ SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE DEVICES ARE JAMMED AS COMPLAINED. IF THE COMPRESSION TOOL IS USED AS INTENDED, IT WILL BE NEVER FULLY TIGHTENED INTO THE CONNECTING SCREW LIKE IN THIS CASE. AS STATED ABOVE, THE MAXIMUM INSERTION DEPTH WOULD BE 41MM, WHILE THE RECEIVED TOOL IS FULLY INSERTED AT A DEPTH OF 43MM. IN THE CURRENT CONDITION, THE IS NO SPACE LEFT FOR THIS DYNAMIC LOCKING SCREW, WHICH IS ALSO VISIBLE ON THE PICTURE WITH THE ASSEMBLED NAIL. WITH THE PROVIDED INFORMATION, THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. BASED ON THE FINDINGS, WE CAN ONLY ASSUME THAT EITHER THE INSERTION HANDLE/NAIL CONNECTION WAS TIGHTENED WITH THE COMPRESSION TOOL BEFORE THE LOCKING SCREW WAS IN PLACE OR THAT THE COMPRESSION DEVICE WAS OVERTIGHTENED WITH THE LOCKING SCREW IN PLACE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE COMPRESSION DEVICE AND CONNECTION SCREW STUCK TOGETHER AND WERE UNABLE TO BE SEPARATED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A COMPRESSION DEVICE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713923 COMPRESSION DEVICE FOR SUPRAPATELLAR INSTRUMENT COMPRESSION HWN OBERDORF SYNTHES PRODUKTIONS GMBH T140927 07611819501782

    Patients

    Seq Age Sex Outcome Treatment
    1