BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 6262526 · Received January 18, 2017

    Report

    Report Number
    1719045-2017-10031
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 30, 2016
    Report Date
    December 30, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRX. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART 352.252S, LOT H102291: RELEASE TO WAREHOUSE DATE: JUNE 30, 2016. EXPIRATION DATE: MAY 31, 2025. SUPPLIER: (B)(4). 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 THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, DRAWING REVIEW, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AS RECOMMENDED. PER THE TECHNIQUE GUIDE, 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 DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BROKEN PORTION WAS NOT RECEIVED. THE BREAK IS LOCATED WITHIN APPROXIMATELY 6.2 MM TO 11.2 MM DISTAL TO THE DISTAL EDGE OF THE DRIVE SHAFT HELIX. THE HELIX IS INTACT. THE REAMER HEAD WAS RECEIVED WITH ALL FOUR PROXIMAL PRONGS BROKEN OFF AT THE BASE. THE BROKEN PORTIONS WERE NOT RECEIVED. THE BALANCE OF EACH OF THE DEVICES SHOW SURFACE WEAR BUT ARE IN FUNCTIONAL CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICES ARE ALREADY BROKEN. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR THE TOP LEVEL DRIVE SHAFT ASSEMBLY, THE DRIVE SHAFT COMPONENT, AND THE 13.0 MM REAMER HEAD WAS PERFORMED. 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. THE COMPLAINT CONDITION IS THE RESULT OF FORCE APPLIED TO THE DISTAL END OF THE DRIVE SHAFT AND REAMER HEAD RESULTING IN STRESSES BEYOND THE FAILURE LIMIT. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE BREAKS ARE UNKNOWN. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    IT WAS REPORTED THAT A PATIENT SUSTAINED A RIGHT FEMUR FRACTURE AND WAS TREATED WITH A SYNTHES LATERAL ENTRY FEMORAL NAIL, TWO 6.5 MM RECON SCREWS PROXIMALLY AND A DISTAL 5.0 MM LOCKING SCREW ON AN UNKNOWN DATE. A NON-UNION WAS NOTED ON AN UNKNOWN DATE AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. THE NAIL AND SCREWS WERE EASILY REMOVED. THERE WERE NO REPORTED ISSUES WITH THE HARDWARE. THE HARDWARE WAS INTACT DURING REMOVAL. AFTER HARDWARE REMOVAL, THE SURGEON WENT ON TO HARVEST BONE GRAFT. WHILE HARVESTING FOR BONE GRAFT, THE DRIVE SHAFT AND REAMER HEAD BROKE. THE DRIVE SHAFT BROKE WHERE IT CONNECTS TO THE REAMER HEAD. THE BALL TIP REAMING ROD WAS USED TO EASILY RETRIEVE THE BROKEN DRIVE SHAFT AND BROKEN REAMER HEAD. THERE WERE NO FRAGMENTS. THERE WAS AN APPROXIMATE FIVE (5) MINUTE SURGICAL DELAY. THE SURGEON USED ANOTHER DRIVE SHAFT AND REAMER HEAD AND CONTINUED THE PROCEDURE. A SUBSEQUENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR WAS PERFORMED AND PATIENT WAS REVISED TO A SYNTHES BLADE PLATE AND SCREWS. ROUTINE X-RAYS WERE TAKEN THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. THIS COMPLAINT IS FOR THE BREAKAGE OF THE DRIVE SHAFT AND REAMER HEAD. THE NON-UNION REQUIRING THE REVISION PROCEDURE IS BEING CAPTURED UNDER LINKED (B)(4). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44633 13.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO SYNTHES MONUMENT H102291

    Patients

    Seq Age Sex Outcome Treatment
    1