MAUDE Adverse Event Report: WARSAW ORTHOPEDICS UCSS; BIT, DRILL

Catalog Number 873-007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicaple imaging studies were available for evaluation.Hence, no conclusion can be drawn.

Event Description

It was reported that the patient underwent unspecified spinal procedure.During preparation of right screw hole, bleeding was observed while pulling out the drill.Blood pressure was dropped at once.Vertebral artery (va) damage was suspected because amount of bleeding reached 600ml.It was stopped by the astriction for 30 min and screw was inserted and the incision was closed.After the surgery, it was checked by angio-ct and the surgeon commented there was no problem in va.The surgical time was extended more than 60 min.No product problem was reported.Surgeon told that the cause was unknown.

• Brand Name: UCSS
• Type of Device: BIT, DRILL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5485415
• MDR Text Key: 39841284
• Report Number: 1030489-2016-00632
• 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: 02/15/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 873-007
• Device Lot Number: NG15C018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2015
• 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