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	Radiation Exposure, Unintended (3164)
Date of Event	05/22/2019
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.Telephone: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while the healthcare professional was performing craniotomy, the craniotome bur snapped.No patient impact reported.On follow up, it was reported and confirmed with hcp that there was a 30 minute delay during the procedure.There was a need to perform an additional x-ray procedure as a result of the event.Patient is currently doing well.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool returned was used and broken.Fracture geometry and location were consistent with tool exit from attachment where the greatest stress in bending.The most likely cause of failure was fatigue in plane bending and can be caused when the tool is pressed to dissect or a side load was applied to the tool while it was not rotating.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.

• 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: 8711693
• Report Number: 1625507-2019-00046
• Device Sequence Number: 11235009
• Product Code: HBE
• UDI-Device Identifier: 00643169766266
• UDI-Public: 00643169766266
• 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): 09/12/2019

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: 02/10/2024
• Device Model Number: F2/8TA23S
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0217029908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1