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	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No conclusion can be drawn.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that tool broke during craniotomy.It was reported that there was no patient or staff impact.Additional information regarding product return is being followed up from the contact person.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool received has a lot number of 0217029912 which was different from the reported lot number of 0215877925.It was noted that the tool returned was used and broken.It was also noted that fracture was perpendicular to axis of rotation and relatively planar and the spinal portion of tool was covered in bio-material.The most likely cause of failure was fatigue in plane bending because a side load was applied to the tool while it was not rotating.If information is provided in the future, a supplemental report will be issued.

• 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: 8928359
• Report Number: 1625507-2019-00091
• Device Sequence Number: 19384698
• 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,Followup
• Report Date (Section B): 10/03/2019

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: 07/29/2023
• 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: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1