BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16.5MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 6891719 · Received September 25, 2017

    Report

    Report Number
    1719045-2017-10975
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982194596
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. THE DISTAL TIP OF ONE RIA DRIVE SHAFT (314.743, 9895470), AND THE PROXIMAL PRONGS OF TWO RIA REAMER HEADS (352.258, H091628 AND 352.263 LOT # 5847628) BROKE INTRAOPERATIVELY ON (B)(6) 2017. NO PROLONGATION OF SURGERY WAS REPORTED AND NO INFORMATION ABOUT PATIENT OUTCOME. ADDITIONALLY IT WAS DISCOVERED THAT ONE REAMER HEAD (352.259, 9842342) WAS NOT ABLE TO BE REMOVED FROM THE RETAINER TIP OF A RIA TUBE ASSEMBLY. TWO CONCOMITANT DISTAL RETAINER COMPONENTS (314.744.7) OF TWO TUBE ASSEMBLIES (314.745 AND/OR 314.746) WERE ALSO RETURNED, BUT WERE NOT FOUND TO HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. THE RETURNED PARTS ARE INCLUDED IN THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM USED FOR INTRAMEDULLARY REAMING AND BONE HARVESTING. THE RIA DRIVE SHAFT (314.743, 9895470) WAS RECEIVED WITH ITS DISTAL TIP WHICH IS INTENDED TO COUPLE WITH REAMER HEADS, BROKEN OFF. ONE OF THE REAMER HEADS (352.258, H091628) WAS RETURNED WITH TWO OF ITS PROXIMAL PRONGS BROKEN OFF; ANOTHER REAMER HEAD (352.263, 5847628) WAS RETURNED WITH ALL FOUR OF ITS PROXIMAL PRONGS BROKEN OFF. A THIRD REAMER HEAD (352.259, 9842342) WAS RETURNED STILL ATTACHED TO A RETAINER COMPONENT OF A TUBE ASSEMBLY. UPON INSPECTION, THE REPORTED COMPLAINT CONDITIONS WERE CONFIRMED, WHICH MADE THEIR REPLICATION INAPPLICABLE. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED. THE RELEVANT DRAWINGS OF THE RETURNED PARTS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO MRRS, NCRS, OR ACTIONS RELATED TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION OF THE RETURNED PART(S). REVIEW OF DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT(S) WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR WHY THE APPROXIMATELY 21.5MM DISTAL TIP (314_741) MEANT TO ENGAGE WITH REAMER HEADS, BROKE OFF. IT IS POSSIBLE THAT THE DAMAGE OCCURRED WHILE ATTEMPTING TO REAM EXCESSIVELY DENSE BONE, WHICH COULD HAVE EXPOSED THE DISTAL TIP OF THE DRIVE SHAFT TO EXCESSIVE TORQUE. REAMING OF EXCESSIVELY DENSE BONE COULD HAVE ALSO CONTRIBUTED TO THE RETURNED REAMER HEAD HAVING BROKEN PROXIMAL PRONGS. UPON RECEIPT OF THE RETURNED REAMER HEAD WHICH WAS RECEIVED STILL ATTACHED TO A RETAINER COMPONENT, THE ATTACHED REAMER HEAD WAS ABLE TO BE REMOVED, USING THE GUIDANCE FOUND IN THE RELEVANT RIA TECHNIQUE GUIDE. THE ROOT CAUSE FOR THE DRIVE SHAFT FAILURES IS ATTRIBUTED TO HUMAN ERROR, SPECIFICALLY MISALIGNMENT DURING ASSEMBLY AND TORQUEING OVER SPECIFICATION, AND IS NOT DESIGN RELATED. SURGICAL TECHNIQUE GUIDES FOR THE RIA SYSTEM INCORPORATE CLEAR AND EXPLICIT PRECAUTIONARY STATEMENTS REGARDING PATIENT RISK IF DEVICE IS NOT ASSEMBLED PROPERLY. DURING THE INVESTIGATION NO UNIDENTIFIED 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HRX . DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 352.259, LOT# 9842342. MANUFACTURED BY: MARK TWO ENGINEERING COMPANY, PACKAGED BY: SYNTHES (B)(4), RELEASE TO WAREHOUSE DATE: AUG 24, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT 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

    UPON RECEIPT OF THE DEVICES AT MANUFACTURER AND DURING PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES, IT WAS IDENTIFIED THAT THE RIA REAMER HEAD WAS STUCK INSIDE THE TUBE ASSEMBLY AND NOT A DRILL BIT AS REPORTED BY COMPLAINANT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO REAMER HEADS BROKE OFF AT THE PROXIMAL END. IN ADDITION THE TIP OF THE REAMING ROD BROKE OFF AND THE DRILL BIT COULD NOT BE REMOVED FROM TUBE ASSEMBLIES. THIS HAPPENED INTRAOPERATIVELY ON (B)(6) 2017. IT WAS FURTHER REPORTED THAT IN ADDITION, THE TIP OF THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SHAFT BROKE OFF AND THE REAMER COULD NOT BE REMOVED FROM TUBE ASSEMBLIES. REAMER HEAD WAS BENT BECAUSE IT WAS STUCK IN THE TUBE ASSEMBLY. NO PROLONGATION OF SURGERY WAS REPORTED AND NO INFORMATION ABOUT PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 16.5 MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672104 16.5MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO SYNTHES MONUMENT 9842342 10886982194596

    Patients

    Seq Age Sex Outcome Treatment
    1