BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 4824333 · Received June 8, 2015

    Report

    Report Number
    3003875359-2015-10254
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITION PATIENT INFORMATION: PATIENT'S HEIGHT IS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT EVALUATION INVESTIGATION WAS PERFORMED: THE COMPLAINT CONDITION FOR THE 03.010.065 LOT NUMBER 3231861 8.0MM/4.2MM DRILL SLEEVE, 03.010.048 LOT NUMBER 5621602 RECON LOCKING AIMING ARM, 03.010.045 LOT NUMBER 3300665 STANDARD INSERTION HANDLE, AND TWO 03.010.044 LOT NUMBERS U110261 AND P527231 CANNULATED CONNECTING SCREW WAS LIKELY CAUSED BY A SOFT TISSUE OBSTRUCTION OR INSUFFICIENT TIGHTENING OF THE AIMING DEVICES; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES WERE RETURNED AND REPORTED TO HAVE CONTRIBUTED TO THE DRILL BIT NOT COLLIDING WITH THE NAIL INSTEAD OF PASSING THROUGH A LOCKING HOLE. THIS CONDITION IS UNCONFIRMED; WHEN TESTED WITH A TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL AND 12.0MM/8.0MM PROTECTION SLEEVE THE DEVICES ALIGN PROPERLY WITH EACH OF THE NAIL¿S LOCKING HOLES. IT IS LIKELY THAT SOFT TISSUE OBSTRUCTED THE PATH OF THE LOCKING SCREWS OR THAT THE AIMING DEVICES WERE NOT FASTENED TOGETHER ENTIRELY LEADING TO THIS COMPLAINT CONDITION. THE 03.010.045 INSERTION HANDLE WAS MANUFACTURED IN 12/2009 AND IS OVER FIVE YEARS OLD. THE DEVICE IS IN FAIRLY WORN CONDITION WITH SEVERAL SCRAPES AND MARKINGS. THE 03.010.048 AIMING ARM WAS MANUFACTURED IN 11/2007 AND IS OVER SEVEN YEARS OLD. THE AIMING ARM IS IN FAIRLY WORN CONDITION. THE 03.010.065 DRILL SLEEVE WAS MANUFACTURED IN 8/2009 AND IS OVER FIVE YEARS OLD. THE DRILL SLEEVE IS IN FAIRLY GOOD CONDITION SHOWING VERY FEW SIGNS OF WEAR. THE 03.010.044 LOT NUMBER U110261 CONNECTING SCREW WAS MANUFACTURED IN 2/2010 AND IS OVER FIVE YEARS OLD. THE DEVICE IS IN FAIRLY WORN CONDITION WITH SOME MILD DISCOLORATION. THE 03.010.044 LOT NUMBER P527231 CONNECTING SCREW WAS MANUFACTURED IN 2005 AND IS ABOUT TEN YEARS OLD. THE DEVICE IS IN FAIRLY WORN CONDITION WITH SOME DEFORMATION OF THE DISTAL THREADS. DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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: THE RESULTS OF THAT REVIEW WERE REPORTED ON THE INITIAL MEDWATCH. INCLUDING THE CODE IN THIS REPORT AS REFERENCE TO ITS COMPLETION. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A BILATERAL FEMUR FRACTURE WHILE IN AN ACCIDENT DRIVING A QUAD. DURING THE BILATERAL LATERAL ENTRY FEMORAL RECON NAIL (LEFN) PROCEDURE ON (B)(6) 2015, THERE WAS AN ISSUE WITH THE AIMING ARM. THE SURGEON WAS USING THE DRILL BIT TO LOCK THE LATERAL ENTRY FEMORAL NAIL PROXIMALLY ON BOTH LEFT AND RIGHT FEMUR. WHEN HE TRIED TO INSERT A SCREW, BY USING THE FIRST DRILLING ON THE STATIC LOCKING HOLE PROXIMAL THROUGH THE AIMING ARM, THE DRILL BIT CONTACTED THE NAIL AND MISSED THE HOLE WHEN HE WAS DRILLING BOTH TIMES ON THE LEFT AND RIGHT SIDES. HE HAD TO REMOVE THE INNER SLEEVE AND FREE HANDED THE DRILL BIT THROUGH THE HOLE IN THE NAIL TO FINISH THE PROCEDURE. EVENTUALLY THE SURGEON WAS ABLE TO GET THE BIT THROUGH THE HOLE IN THE NAIL FOR THE SCREW TO BE INSERTED SUCCESSFULLY. THERE WAS A SURGICAL TIME DELAY OF TEN MINUTES REPORTED. THERE WAS NO SURGICAL/MEDICAL INTERVENTION REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT STATUS OUTCOME IS GOOD. THIS COMPLAINT INVOLVES NINE DEVICES. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368070 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 3300665

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR