MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS TOOL MR8 DISSECTING; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-SP14MH30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Unintended Radiation Exposure (4565)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that device was fractured.The likely cause of failure could not be determined.The user manual contains the following warning ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.¿ we will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the burr tip broke off during use in spinal decompression, all fragments were accounted for and intraoperative x-ray was taken.On follow up it was reported that the fragments were removed from the patient and due to x-ray intervention the procedure got delayed for 15 minutes.It was also reported that the name of the procedure was laminectomy.Event notified on: 2022-04-14.

• Brand Name: TOOL MR8 DISSECTING
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 14399493
• Report Number: 1625507-2022-00091
• Device Sequence Number: 5551337
• Product Code: HBE
• UDI-Device Identifier: 00763000047153
• UDI-Public: 00763000047153
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2025
• Device Model Number: MR8-SP14MH30
• Device Catalogue Number: MR8-SP14MH30
• Device Lot Number: 0223539635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 132 KG