BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40(TM). RASP HANDLE

    MDR report key: 3032146 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01178
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN EXETER RASP HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. THE RETURNED INSTRUMENT IS DAMAGED. THERE WAS DAMAGE FROM CONTACT WITH HARD OBJECTS OBSERVED AT AND NEAR THE FRACTURE LOCATION. THERE WAS A FISSURE NEAR THE LOCKING MECHANISM ON THE BODY OF THE RETURNED INSTRUMENT. THE FRACTURE SURFACE EXHIBITED EXTENSIVE POST-FRACTURE ABRASION OBSCURING THE ORIGINAL FRACTURE MORPHOLOGY. THE HARDNESS WAS MEASURED IN (B)(4) FOR THE RASP HANDLE AND THE DEVICE WAS WITHIN SPECIFICATION. (B)(4) ALSO CONFIRMED THAT DURING MANUFACTURING, HEAT TREATMENT WAS PERFORMED ACCORDING TO SPECIFICATION. DEVICE HISTORY REVIEW FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW SHOWED THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED HOWEVER BOTH THE MAR REPORT AND THE SUPPLIER INVESTIGATION CONCLUDED THAT THERE WAS DAMAGE FROM CONTACT WITH HARD OBJECTS OBSERVED AT AND NEAR THE FRACTURE LOCATION. THERE WAS A FISSURE NEAR THE LOCKING MECHANISM ON THE BODY OF THE RETURNED INSTRUMENT. THE FRACTURE SURFACE EXHIBITED EXTENSIVE POST-FRACTURE ABRASION OBSCURING THE ORIGINAL FRACTURE MORPHOLOGY. ((B)(4)), CONCLUDED THAT THE FISSURE IS VERY LIKELY A CONSEQUENCE OF A FATIGUE FRACTURE DUE TO THE EXCESSIVE CONDITION OF USE, AS IT WAS ANALYZED IN THE NCR (B)(4) CLOSED IN 2010. NO ACTION IS REQUIRED AT THIS TIME AS THERE WAS NO INDICATION OF A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SURGEON AT RANDER'S HOSPITAL, TO OUR SALES REP, THAT RASP HANDLES FOR EXETER CRACKED DURING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SURGEON AT (B)(6)'S HOSPITAL, TO OUR SALES REP, THAT RASP HANDLES FOR EXETER CRACKED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135967 EXETER V40(TM). RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G106517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other