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

Model Number	F2/8TA23S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that three distal (tang end) pieces and three proximal (fluted end) pieces were returned fractured and used.It was noted that for all returned tools, the fracture location adjacent to tool exit from attachment, point greatest stress in bending.Cut testing with f2/8ta23s burs indicates that this tool cannot sustain the same cutting pressure as a non-spiral f2 tool.The most likely cause of failure is fatigue in plane bending.The tool was pressed to dissect as rapidly as a f2/8ta23 or a side load was applied to the tool while it was not rotating.If the fracture happened during forward dissection, it is recommended to the customer to use lighter tip pressure while cutting or switching to a non-spiral f2 tool.If the fracture happened during a prying action, the ifu cautions against this.The user manual contains the following warning ¿bending or prying may break the accessory, causing harm to patient or staff.Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection." 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 six tools of the same lot number were broken in the same surgery.It was reported that there was no patient impact.

• Brand Name: LEGEND TAPERED 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: 8870715
• Report Number: 1625507-2019-00082
• Device Sequence Number: 14276562
• Product Code: HBE
• UDI-Device Identifier: 00643169766266
• UDI-Public: 00643169766266
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 08/07/2019

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: 02/06/2024
• Device Model Number: F2/8TA23S
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0217029912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1