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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS BIT, DRILL

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WARSAW ORTHOPEDICS BIT, DRILL Back to Search Results
Device Problem Mechanical Jam (2983)
Patient Problems Spinal Column Injury (2081); Blood Loss (2597)
Event Date 05/21/2019
Event Type  Injury  
Manufacturer Narrative
The following products were used in the surgery: product id: 873-007, lot:unk; product id: 873-004, lot: kh17m064.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent fixation using magerl surgery at c1/2 due to atlantoaxial subluxation.Intra-op, during drilling the guide wire advanced.It was difficult to remove the guide wire from the drill and it was removed with a plier.There was a blood coagulation site 10 mm above the guide wire thread and the portion got stuck was drilled and hemorrhage occurred and vertebral artery got injured.The instrument was inserted near c3 in another skin incision.It is unknown if the anterior bone surface was ruptured or not at that time.When removing the guide wire and drill bit due to sticking, there was bleeding from the vertebral artery.It was that kind of bleeding that the operative field was covered with blood.Hemostasis by compression was performed, and bleeding stopped.As the physician give up inserting the screw on the left side, and the operation was completed with fixation only performed on the right side.When the removed guide wire was confirmed, there was something like coagulated blood on the guide wire and it seemed to stick and interfere with the drill.After removing the thing on guide wire, the guide wire passed through the drill without any problem.Since the guide wire did not deform, something like coagulated blood on the guide was considered to be the cause.There was no problem with the action of both hands after the patient woke up.
 
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Brand Name
BIT, DRILL
Type of Device
BIT, DRILL
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8715796
MDR Text Key148525362
Report Number1030489-2019-00643
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received06/20/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age71 YR
Patient Weight67
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