BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CHAMFER REAMER STAR ANKLE 7.5MM

    MDR report key: 5168509 · Received October 22, 2015

    Report

    Report Number
    0008031020-2015-00425
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 30, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6), HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE ANTERIOR CHAMFER REAMER STAR ANKLE 7.5 MM TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE RECEIVED ANTERIOR CHAMFER REAMER SHOWED TRACES OF AN INTENSE USE. THE CUTTING EDGES WERE SIGNIFICANTLY WORN AND DEGRADED. THE REAMER WAS NOT SHARP ANYMORE. THE BACK OF THE E-CLIP WAS SIGNIFICANTLY ABRADED AND HEAVILY DEFORMED. THE APPEARANCE OF THE ANTERIOR CHAMFER REAMER LIKE SIGNIFICANT HELICAL MATERIAL ABRASION AND DEFORMATION OBSERVED ON THE STOP COLLAR SLEEVE WAS MOST LIKELY THE RESULT OF EXCESSIVE HANDLING. THE APPEARANCE OF THE DAMAGE INDICATED THAT THE E-CLIP OF THE REAMER WAS PUSHED OUT OF ITS CIRCUMFERENTIAL GROOVE MOST LIKELY CAUSED BY A FATIGUE FAILURE OF THE THREE LEGS OF THE E-CLIP, WHICH WERE SIGNIFICANTLY DEFORMED LIKELY DUE TO HEAT AND LOAD DURING SURGERY LEADING TO THE E-CLIP BEING FREELY MOVABLE ON THE REAMER SHAFT. AT THIS POINT THE STOP COLLAR SLEEVE WAS NO LONGER SECURED AND WAS ALSO AXIALLY MOVEABLE, WHICH HAD LED TO AN INCREASE OF THE DEPTH LENGTH. WITHOUT A SECURED STOP COLLAR SLEEVE THE ANTERIOR CHAMFER REAMER WOULD NO LONGER STOP AT ITS REQUIRED DEPTH RESULTING IN A DEEPER REAMING INTO THE TALUS BONE, WHICH HAD OCCURRED IN THE ACTUAL CASE. THIS HAD REQUIRED FILLING WITH BONE AND CEMENT. THE DAMAGE FOUND ON THE REAMER SHAFT AND ON THE E-CLIP INDICATED THAT THE REAMER WAS OPERATED WITHIN THE CUTTING GUIDE SLOTS MOST LIKELY WITH HEAVY BENDING FORCES AND EXCESSIVE PRESSURE TOWARDS SUPERIOR AND INFERIOR IN THE LAST RESPECTIVELY IN ONE OF THE FORMER SURGERIES, CAUSING A DEFORMATION OF THE STOP COLLAR SLEEVE. WITH THE GIVEN INFORMATION IT COULD NOT BE DETERMINED WHEN THE FOUND DAMAGE HAD OCCURRED. IT COULD ALSO NOT BE IDENTIFIED IF THE ANTERIOR CHAMFER REAMER IN QUESTION BECAME PRE-DAMAGED IN ONE OF THE FORMER SURGERIES OR IF THE DEVICE DAMAGED IN THE LAST ONE. THE IFU ADVISES THAT INSTRUMENTS SHALL BE PRE-CHECKED BEFORE EVERY SURGERY REGARDING DAMAGE / DEFORMATION AND THAT THEY SHALL BE USED WITH CARE. BASED ON THE ABOVE OBSERVATIONS, A DEFICIENCY IN MANUFACTURING OF THE ANTERIOR CHAMFER REAMER IN QUESTION WAS NOT VERIFIED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AS HE WAS USING THE CHAMFER REAMER, THE METAL STOP DISC MOVED ON THE REAMER AND HE OVER DRILLED. THE SURGEON REPORTED THAT HE DID NOT TAKE ANY MEASURES TO CLOSE THE GAP, ASSUMING THAT THE BONE WOULD RE-GROW AND THE CASE WAS COMPLETED. IT IS UNKNOWN AT THIS POINT WHETHER THERE WILL BE ANY LASTING CONSEQUENCES FOR THE PATIENT AS THE PATIENT IS IN A CAST AND IT WILL BE 6 WEEKS BEFORE THE PATIENT CAN WEIGHT BEAR.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AS HE WAS USING THE CHAMFER REAMER, THE METAL STOP DISC MOVED ON THE REAMER AND HE OVER DRILLED. THE SURGEON REPORTED THAT HE DID NOT TAKE ANY MEASURES TO CLOSE THE GAP, ASSUMING THAT THE BONE WOULD RE-GROW AND THE CASE WAS COMPLETED. IT IS UNKNOWN AT THIS POINT WHETHER THERE WILL BE ANY LASTING CONSEQUENCES FOR THE PATIENT AS THE PATIENT IS IN A CAST AND IT WILL BE 6 WEEKS BEFORE THE PATIENT CAN WEIGHT BEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699310 ANTERIOR CHAMFER REAMER STAR ANKLE 7.5MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 100-3007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other