BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 4939298 · Received July 24, 2015

    Report

    Report Number
    2520274-2015-15008
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 13, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT - MINIMUM 520MM LENGTH ¿ FOR USE WITH RIA (REAMER / IRRIGATOR / ASPIRATOR) PART NUMBER 314.743, LOT 7432391. THE CERTIFICATE OF COMPLIANCE AND THE CERTIFICATE OF CONFORMANCE INDICATED THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 12, 2014. A PRODUCT INVESTIGATION WAS COMPLETED: ONE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH REAMER/IRRIGATOR/ASPIRATOR (RIA) (PART NUMBER 314.743, LOT NUMBER 7432391) WAS RECEIVED. FURTHER EVALUATION AT THE COMPLAINT HANDLING UNIT SHOWS 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. PER THE TECHNIQUE GUIDE, THE RIA SYSTEM IS INTENDED FOR USE TO CLEAR THE MEDULLARY CANAL, TO SIZE THE MEDULLARY CANAL FOR IMPLANTS OR PROSTHESIS, TO HARVEST BONE AND BONE MARROW, AND TO REMOVE INFECTED AND NECROTIC BONE IN THE TREATMENT OF OSTEOMYELITIS. THE RETURNED DRIVE SHAFT WAS RECEIVED WITH THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BREAK IS ROUGHLY TRANSVERSE AND LOCATED WITHIN 1.5MM TO 2.5MM DISTAL TO THE DISTAL EDGE OF THE DRIVE SHAFT HELIX. THE HELIX IS INTACT AND THE BROKEN TIP IS APPROXIMATELY 24.2MM LONG. THE BROKEN PIECE SHOWS SIGNIFICANTLY SCRAPED EDGES AND APPEARS TO BE CRACKING. THE CONNECTING POST SHOWS SCRAPING AND SMALL DENTS. THE BALANCE OF THE DEVICE IS IN WORKING CONDITION WITH ONLY SURFACE SCRATCHES. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT CANNOT BE REPLICATED AS THE SHAFT IS ALREADY BROKEN. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE CONDITION OF THE RETURNED DRIVE SHAFT IS CONSISTENT WITH DAMAGE CAUSED BY EXCESSIVE FORCE. IT IS CRITICAL FOR THE RELIABLE FUNCTION OF THE DRIVE SHAFT THAT A CANNULATED DRIVE UNIT THAT DELIVERS ONLY 3.5-4.5NM OF TORQUE AND 700-900RPM BE USED. THE TECHNIQUE GUIDE STATES THAT NO REDUCTION DRIVE OR DRILLS WITH A TORQUE GREATER THAN 6NM BE USED. THE DEVICE WAS REPORTED TO HAVE BEEN FOUND IN THE BROKEN CONDITION, THUS, SPECIFIC DETAILS REGARDING THE CIRCUMSTANCES AT THE TIME OF THE DAMAGE ARE UNKNOWN. HOWEVER IT IS MOST PROBABLE THAT THE HANDLING OF THE DEVICE RESULTED IN EXCESSIVE FORCE TO THE DISTAL TIP AND/OR USE OF AN INCORRECT DRIVE UNIT REPEATEDLY OVER TORQUED THE DRIVE SHAFT LEADING TO FATIGUE AND ULTIMATELY THE FRACTURE AT THE DISTAL TIP. 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 THE TIP OF A REAMER IRRIGATOR ASPIRATOR DRIVE SHAFT WAS FOUND TO HAVE BROKEN OFF INTO TWO PIECES. THIS WAS DISCOVERED IN STERILE PROCESSING. NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482257 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7432391

    Patients

    Seq Age Sex Outcome Treatment
    1