BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING ATTACHMENT 1.2NM

    MDR report key: 4819547 · Received June 4, 2015

    Report

    Report Number
    3009450871-2015-12044
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    LXH
    PMA / PMN Number
    PK072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION INVESTIGATION WAS PERFORMED: THE RETURNED HANDLE WITH MINI QUICK COUPLING (311.01, 5812395) WAS RECEIVED WITH THE HEAD REGION WHICH IS DESIGNED TO ACCEPT ATTACHMENTS NOT SLIDING PROPERLY. THE HANDLE WITH MINI COUPLING IS INCLUDED IN SEVERAL TECHNIQUE GUIDES AND IS DESIGNED TO ACCEPT A VARIETY OF SCREW INSERTION ATTACHMENTS WHICH ARE DESIGNED TO MATE WITH MINI QUICK COUPLING TIPS. THE RETURNED HANDLE WITH MINI QUICK COUPLING WAS MANUFACTURED ON 23JUN08 AND DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON INSPECTION OF THE RETURNED HANDLE WITH MINI QUICK COUPLING IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THE HANDLE DID NOT EXHIBIT ANY SIGNS OF MISUSE, BUT THE MECHANISM IN THE BODY SUB-ASSEMBLY WHICH IS RESPONSIBLE FOR ENGAGING WITH ATTACHMENTS WAS POSSIBLY COMPROMISED DUE TO HEAVY USAGE OR USING THE HANDLE/ATTACHMENT ASSEMBLY IN AN UNINTENDED WAY WHICH EXPOSED THE INTERLOCKING MECHANISM TO UNEXPECTED FORCES AND SUBSEQUENTLY DAMAGED IT AND PREVENTED IT FROM WORKING AS INTENDED. 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

    PATIENT INITIALS ARE (B)(6). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. AN IMPLANT DATE WAS REPORTED ON THE INITIAL MEDWATCH. THIS DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ORIGINAL IMPLANT DATE IS (B)(6) 2015. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 05. NOV. 2013. 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 SURGEON WAS USING THE TORQUE LIMITING ATTACHMENT 1.2NM WHEN THE QUICK COUPLING BEGAN TO DISCONNECT FROM THE BASE OF THE UNIT. SURGEON IMMEDIATELY STOPPED THE DRILL AND CONTINUED THE SURGERY WITHOUT THE TORQUE LIMITING ATTACHMENT 1.2NM. IT WAS ALSO REPORTED THAT THE HANDLE WITH MINI QUICK COUPLING WOULD NOT ENGAGE THE SCREWDRIVER AND COUNTERSINK ATTACHMENTS. A SEPARATE HANDLE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED LESS THAN A MINUTE TO CORRECT THE ISSUE. PATIENT WAS SUCCESSFULLY TREATED WITHOUT ANY OTHER ISSUES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363078 TORQUE LIMITING ATTACHMENT 1.2NM MISC ORTHO SURGICAL INSTRUMENT LXH DEPUY SYNTHES POWER TOOLS 1000349

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR