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

Model Number	9TA30
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
No conclusion can be drawn.No evaluation was performed, as the device was discarded by the customer.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 during surgery, the burr was broken and the tip of the burr was left inside the patient's left knee.It was confirmed by a post-surgery x-ray and it was considered safe to be left in the bone.On follow-up, it was reported that there will be no revision surgery to remove the broken piece and the remaining part of the tool was discarded by the customer.It was also reported that no further information can be provided regarding the event and the status of the patient post-surgery.

• Brand Name: LEGEND DISSECTING TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 11388328
• Report Number: 1625507-2021-00040
• Device Sequence Number: 4568314
• Product Code: HBE
• UDI-Device Identifier: 00643169766037
• UDI-Public: 00643169766037
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 10/20/2025
• Device Model Number: 9TA30
• Device Catalogue Number: 9TA30
• Device Lot Number: 0220930856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other