BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE

    MDR report key: 4824388 · Received June 8, 2015

    Report

    Report Number
    2520274-2015-14296
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    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). LOT NUMBER 2527231 PROVIDED; THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). 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. MFR DATE: UNKNOWN. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUPPLIER LOT NUMBER OF THE SUBJECT DEVICE IS P527231, THIS NUMBER IS ASSOCIATED WITH SYNTHES LOT NUMBERS 4996344, 4996478, 5015912, 5015913, 5072191, AND 5131740. PLEASE NOTE THAT LOT NUMBER 4996344 WAS RETURNED TO THE SUPPLIER AND NOT RELEASED. ADDITIONAL DATES OF MANUFACTURE ARE JUN 21, 2005, SEP 30, 2005 AND DEC 19, 2005. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE SUPPLIER LOT. (B)(4) MANUFACTURED THE CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE, PART NUMBER 03.010.044, AND LOT NUMBERS 4996344, 4996478, 5015912, 5015913, 5072191, AND 5131740 (SUPPLIER LOT P527231). SYNTHES LOT 4996344 WAS INSPECTED TO INCOMING FINAL INSPECTION SHEET DATED 4/26/05. THE C OF C WAS DATED 4/27/05. MRR (B)(4) WAS GENERATED FOR UNDERSIZED SHAFT DIAMETER, CANNULATION DIAMETER UNDERSIZED, HEX OVERSIZED, THREAD OVERSIZED, AND THREAD LENGTH NOT TO SPECIFICATION. THE ENTIRE RECEIPT OF (B)(4) PIECES WAS RETURNED TO THE SUPPLIER AND THE MRR WAS CLOSED 5/2/05. SYNTHES LOT 4996478 WAS INSPECTED TO INCOMING FINAL INSPECTION SHEET DATED 4/27/05. THE C OF C WAS DATED 4/27/05. NO MRRS WERE GENERATED FOR THIS RECEIPT AND THE (B)(4) PIECES OF THIS LOT WERE RELEASED 4/28/05. SYNTHES LOT 5015912 WAS INSPECTED TO INCOMING FINAL INSPECTION SHEET (DATED 5/26/05). THE C OF C WAS DATED 5/26/05. NO MRRS WERE GENERATED FOR THIS LOT AND THE (B)(4) PIECES WERE RELEASED 6/21/05. SYNTHES LOT 5015913 WAS INSPECTED TO INCOMING FINAL INSPECTION SHEET (DATED 5/26/05). THE C OF C WAS DATED 5/26/05. MRR (B)(4) WAS GENERATED FOR ROUGH SURFACE FINISH. THE ENTIRE RECEIPT OF 78 PIECES WAS RETURNED TO THE SUPPLIER AND THE MRR WAS CLOSED 5/31/05. SYNTHES LOT 5072191 WAS INSPECTED TO INCOMING FINAL INSPECTION (DATED 9/14/05). THE C OF C WAS DATED 8/26/05. MRR (B)(4) WAS GENERATED FOR UNDERSIZED SHAFT DIAMETER. ONE PIECE WAS RETURNED TO THE SUPPLIER AND THE MRR WAS CLOSED 9/23/05. THE REMAINING PIECES OF THIS LOT WERE RELEASED 9/30/05. SYNTHES LOT 5131740 WAS INSPECTED TO INCOMING FINAL INSPECTION SHEET (DATED 12/8/05). THE C OF C WAS DATED 12/6/05. MRR (B)(4) WAS GENERATED FOR UNDERSIZED SHAFT DIAMETER. THE PARTS WERE DISPOSITIONED "USE-AS-IS." THE MRR WAS CLOSED 12/13/05, AND THE PARTS WERE RELEASED 12/19/05. 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

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE REQUESTED NOW THAT A LOT NUMBER HAS BEEN RECEIVED. RESULTS TO BE REPORTED UPON COMPLETION. 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 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369268 CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE GUIDE FZX SYNTHES MONUMENT P527231

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR