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

Model Number	MC254
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was discarded.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.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 during reconstruction of vertebral body, the surgeon used the metal cutter to cut the pyramesh lumbar cage.However, sparks suddenly appeared upon contact between the bur and the cage.The surgeon decided to try it again but the result is the same.Due to this, the surgeon decided to stop using the cutter and just used pliers to continue the procedure.It was reported that there was no clinical consequences but there was a burn/fire risk for both patient and the health care provider inside the operating room.It was also reported that there was a procedure delay and the device has been discarded by the customer.On follow-up, it was reported that there was no further information that can be provided regarding the procedure delay.

• Brand Name: TOOL LEGEND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 11996247
• Report Number: 1625507-2021-00140
• Device Sequence Number: 19062989
• Product Code: HBE
• UDI-Device Identifier: 00643169760974
• UDI-Public: 00643169760974
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: MC254
• Device Catalogue Number: MC254
• Device Lot Number: 0221467769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PYRAMESH CAGE (L/N: UNKNOWN)
• Patient Age: 70 YR
• Patient Weight: 101