BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6303264 · Received February 6, 2017

    Report

    Report Number
    2520274-2017-10387
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 13, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR TWO (2) UNKNOWN 5.0MM LOCKING SCREW SHAFT FRAGMENTS THAT WERE RETAINED IN THE PATIENT. PART AND LOT NUMBERS WERE NOT PROVIDED FOR REPORTING. THE PATIENT WAS IMPLANTED WITH THE FOLLOWING SCREWS: 422.392, 5.0MM TI LOCKING SCREW SELF-DRILLING 26MM, QTY 3; 422.393, 5.0MM TI LOCKING SCREW SELF-DRILLING 40MM, QTY 2; 422.396, 5.0MM TI LOCKING SCREW SELF-DRILLING 75MM, QTY 1; AND UNKNOWN, 5.0MM TI LOCKING SCREWS, QTY 3. COMMON NAME FOR PART NUMBERS 422.392 AND 422.393 IS PLATE, FIXATION, BONE. DEVICE CODE IS HRS. 510(K) IS K963325. COMMON NAME FOR PART NUMBER 422.396 IS NAIL, FIXATION, BONE. DEVICE CODE IS JDS. 510(K) IS K962047. IT IS NOT KNOWN WHICH OF THESE SCREWS COULD NOT BE COMPLETELY REMOVED FROM THE PATIENT. FOR THIS REASON COMMON NAME SCREW, FIXATION, BONE AND DEVICE PRODUCT CODE HWC WERE USED. THERAPY DATE: INITIAL DATE OF IMPLANT IS UNKNOWN AND WAS REPORTED ONLY AS AN UNKNOWN DATE IN 2016. DUE TO THE RETAINED FRAGMENTS, THESE SCREWS ARE NOT CONSIDERED TO HAVE BEEN SUCCESSFULLY EXPLANTED ON (B)(6) 2017. THE SUBJECT DEVICES ARE NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. 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 DURING HARDWARE REMOVAL SURGERY ON (B)(6) 2017 AND TWO (2) UNKNOWN 5.0MM TI LOCKING SCREWS DISTAL SHAFTS WERE RETAINED IN THE PATIENT¿S FEMUR. THE PATIENT INITIALLY UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6) 2016 DUE TO DISCOMFORT FROM THE PROMINENT EDGE OF THE IMPLANTED LISS PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN 2016 WITH ONE (1) LESS INVASIVE STABILIZATION SYSTEM (LISS) NINE-HOLE PLATE AND NINE (9) 5.0MM SCREWS TO TREAT A DISTAL FEMUR FRACTURE. THE FRACTURE HAD HEALED BUT THE PATIENT WAS UNCOMFORTABLE WITH THE PROMINENT EDGE ON THE IMPLANTED PLATE. IT WAS DECIDED THAT THE LISS CONSTRUCT WOULD BE REMOVED. DURING THE (B)(6)2016 PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO REMOVE TWO (2) 5.0MM SCREWS, THE SCREW HEADS BECAME STRIPPED. SURGEON CHOSE TO LEAVE THE SCREWS IN PLACE. SURGEON WAS ABLE TO REMOVED ONE (1) 5.0MM TI LOCKING SCREW, BUT WAS UNSUCCESSFUL IN REMOVING THE OTHER EIGHT (8) SCREWS AND PLATE. DUE TO THIS EVENT SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE. THE SECOND HARDWARE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2017. DURING THE PROCEDURE SURGEON REMOVED ONE (1) TITANIUM DISTAL FEMUR LEFT LISS PLATE, THREE (3) 5.0MM TI LOCKING SCREW SELF DRILLING, TWO (2) 5.0MM TI LOCKING SCREW SELF-DRILLING 40MM AND ONE (1) 5.0MM TI LOCKING SCREW SELF DRILLING 75MM. THE TWO STRIPPED (2) 5.0MM TI LOCKING SCREWS REMAIN IN THE PATIENT¿S FEMUR. IT WAS REPORTED THAT THE SURGEON REMOVED THE HEAD PORTION OF THESE TWO SCREWS AND REAMED OUT SOME OF THE INNER PORTION OF THE SHAFT SCREWS. ONLY THE DISTAL PORTION OF THE SHAFT OF THESE SCREWS REMAINED IN THE PATIENT¿S BONE. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT ADDRESSES THE TWO (2) UNKNOWN 5.0MM LOCKING SCREW SHAFT FRAGMENTS THAT WERE RETAINED IN THE PATIENT. PLEASE SEE RELATED COMPLAINTS (B)(4) WHICH ADDRESS AND REPORT THE ADDITIONAL EVENTS RELATED TO THIS PATIENT. CONCOMITANT MEDICAL DEVICES: TI DISTAL FEMUR LISS PLATE 9 HOLES/236MM-LEFT (ITEM # 422.345, LOT # UKNOWN, QUANTITY 1 EACH); 5.0MM TI LOCKING SCREW SELF-DRILLING 26MM (ITEM # 422.392, LOT # UNKNOWN, QUANTITY 3 EACH); 5.0MM TI LOCKING SCREW SELF-DRILLING 40MM (ITEM # 422.393, LOT # UNKNOWN, QUANTITY 2 EACH); 5.0MM TI LOCKING SCREW SELF-DRILLING 75MM (ITEM # 422.396, LOT # UNKNOWN, QUANTITY 1 EACH); 5.0MM TI LOCKING SCREW (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 3 EACH). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86105 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 422.345, TI DISTAL FEMUR LISS PLATE 9 HOLES, QTY 1| 422.392, 5.0MM TI LOCKING SCREW 26MM, QTY 3| 422.393, 5.0MM TI LOCKING SCREW 40MM, QTY 2| 422.396, 5.0MM TI LOCKING SCREW 75MM, QTY 1| UNKNOWN, 5.0MM TI LOCKING SCREWS, QTY 3