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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report inconclusive.The device has been returned and is still pending evaluation results.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.Initial reporter: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the tool broke during surgery.It was also reported that there was no patient impact.Additional information about the event is currently being followed up for further details.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool was returned used and broken.It was noted through microscopic evaluation that the fracture geometry and location are consistent with brittle fracture in bending.It was also noted that discoloration was present and most likely a combination of biomaterial and oxidation of the tool.The likely cause was identified as fatigue in plane bending due to the tool being pressed rapidly as a f2/8ta23 or a side load was applied to the tool while it was not rotating causing the tool to fracture.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
On further follow up, it was confirmed that no other information can be provided regarding patient's current status.

• 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: 8621644
• Report Number: 1625507-2019-00033
• Device Sequence Number: 10858059
• Product Code: HBE
• UDI-Device Identifier: 00643169766266
• UDI-Public: 00643169766266
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 06/17/2023
• Device Model Number: F2/8TA23S
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0215603759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1