BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 5581644 · Received April 15, 2016

    Report

    Report Number
    1719045-2016-10323
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING LOCATION: (B)(4), PACKAGED BY: (B)(4). MANUFACTURING DATE: SEPTEMBER 11, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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

    PRODUCT INVESTIGATION SUMMARY: ONE (1) DRIVE SHAFT FOR USE WITH REAMER/IRRIGATOR/ASPIRATOR (RIA) (PART 314.743 / LOT 6648786); ONE (1) 12.0MM REAMER HEAD (PART 352.250S / LOT 9875460); AND ONE (1) 13.0MM REAMER HEAD (PART 352.252S / LOT 7802659) WERE RECEIVED WITH THE COMPLAINT CATEGORIES OF ¿BROKEN: INTRAOPERATIVELY.¿ THE COMPLAINT CONDITIONS ARE CONFIRMED AS THE DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP BROKEN OFF; ONE REAMER HEAD WAS RECEIVED WITH ALL FOUR PROXIMAL PRONGS BROKEN OFF AT THE BASE; AND THE OTHER REAMER HEAD WAS RECEIVED WITH ONE OF THE PROXIMAL PRONGS BROKEN OFF AT THE BASE. THE BROKEN PORTIONS WERE NOT RECEIVED. THE COMPLAINT CONDITIONS ARE THE RESULT OF AN OVERLOAD OF FORCES TO THE DISTAL END OF THE DRIVE SHAFT RESULTING IN STRESSES BEYOND THE FAILURE LIMIT OF THE SHAFT AND THE REAMER HEAD PRONGS. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE BREAK ARE UNKNOWN. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. FURTHER EVALUATION INDICATES THAT, DURING USE, THE DRIVE SHAFT IS ATTACHED TO THE CORRESPONDING LENGTH REAMER/IRRIGATOR/ASPIRATOR (RIA) TUBE ASSEMBLY AND A REAMER HEAD, AND THEN CONNECTED TO A DRIVE UNIT. THE RIA SYSTEM IS INTENDED FOR USE TO CLEAR THE MEDULLARY CANAL, TO SIZE THE MEDULLARY CANAL, TO HARVEST BONE AND BONE MARROW, AND TO REMOVE INFECTED AND NECROTIC BONE. THE RETURNED DRIVE SHAFT AND REAMER HEADS WERE ALL RECEIVED IN BROKEN CONDITIONS WITH PORTIONS MISSING. THE DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BREAK IS ROUGHLY TRANSVERSE AND LOCATED WITHIN 7.2MM TO 10.1MM FROM THE DISTAL EDGE OF THE DRIVE SHAFT HELIX. THE HELIX IS SIGNIFICANTLY SCRAPED AND WORN DOWN. THE PROXIMAL CONNECTING POST SHOWS SCRAPING ON THE DISTAL FLATS AND WORN EDGES. ONE REAMER HEAD (352.252) WAS RECEIVED WITH ALL FOUR PROXIMAL PRONGS BROKEN OFF AT THE BASE AND THE OTHER REAMER HEAD (352.250) WAS RECEIVED WITH ONE OF THE PROXIMAL PRONGS BROKEN OFF AND TWO OF THE REMAINING PRONGS BENT INWARD. SLIGHT DEFORMATION OF THE OUTER DIAMETER EDGES WAS ALSO NOTED ON THE SECOND REAMER HEAD (352.250). A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR THE TOP LEVEL DRIVE SHAFT ASSEMBLY, THE DRIVE SHAFT COMPONENT, THE 12.0MM REAMER HEAD, AND THE 13.0MM REAMER HEAD WAS PERFORMED. THE RIA TECHNIQUE GUIDE ADDRESSES RECOMMENDED USE AND STATES THAT A CANNULATED DRIVE UNIT THAT DELIVERS ONLY 3.5-4.5NM OF TORQUE AND 700-900RPM IS TO BE USED. THE TECHNIQUE GUIDE ALSO CAUTIONS THAT NO REDUCTION DRIVE UNITS OR DRILLS WITH A TORQUE GREATER THAN 6NM SHOULD BE USED. UNDER ¿REAMING,¿ IT IS RECOMMENDED THAT THE USE BEGIN REAMING BY USING A GRADUAL ADVANCE/RETRACT TECHNIQUE. SLOWLY ADVANCE 20-30MM AND THEN RETRACT 50-80MM ALLOWING THE IRRIGATION FLUID TO FLOW IN FRONT OF THE REAMER HEAD. INFORMATION ON CARE AND MAINTENANCE IS ALSO PROVIDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DRIVESHAFT AND TWO DRILL BITS BROKE DOWN DURING SURGERY. NO INFORMATION ABOUT PATIENT CONDITION RECEIVED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237213 12.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO SYNTHES MONUMENT 9875460

    Patients

    Seq Age Sex Outcome Treatment
    1