MAUDE Adverse Event Report: WARSAW ORTHOPEDICS BIT, DRILL

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.

• 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 Key: 8715796
• MDR Text Key: 148525362
• Report Number: 1030489-2019-00643
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 06/20/2019
• 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 Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 67