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

Model Number	F2/8TA23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report inconclusive.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.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.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a bur snapped while being used in a procedure.The broken piece was retrieved from the patient.It was also reported that the patient was alive with no injury.Upon follow up, it was reported that there was a 20-minute delay due to the use of another blade which caused prolonged anesthetic use.It was confirmed that the incident did not cause any long term harm to the patient and the surgery was completed with no other non-routine activities.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool was returned used and fractured.The tool was received in two pieces and small fragments from the fracture were missing.It was noted through microscopic evaluation that the fracture location is consistent with cracks initiated from impact or surface defect.It was also noted that discoloration was present on the stem in the form of dark circumferential bands relative to location of bearings near tang end of the tool.The likely cause was identified as a combination of the tool making contact with material harder than bone and vibration from lack of bearings supporting the tool adequately.The tool geometry was optimized for dissecting bone and is less effective on materials much harder than bone.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.

• 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: 8439301
• Report Number: 1625507-2019-00018
• Device Sequence Number: 13539147
• Product Code: HBE
• UDI-Device Identifier: 00643169766259
• UDI-Public: 00643169766259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 01/07/2024
• Device Model Number: F2/8TA23
• Device Catalogue Number: F2/8TA23
• Device Lot Number: H5499462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1