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 Codes	Perforation (2001); Injury (2348)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.No evaluation was performed, as the tool was not returned.If the tool is returned in the future, product analysis may be performed.This is a known failure mode that could occur due to excessive pressure, such as bending or prying, on dissecting tools.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 monitor this complaint type for trends.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the craniotome burr snapped during a trauma craniotomy case and damaged the patient's dura.There was a minor delay to change out the burr for another product and the operation completed with no other incident.Additional information is being requested on the patient's current condition and return of the device for analysis.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool returned was used and broken.It was noted that only the distal portion of the tool was received, the proximal portion of the tool was not received.Fracture occurred adjacent to tool exit from attachment and this site is consistent with the point of greatest stress in bending.The likely cause was identified as the tool failed from fatigue in plane bending causing the tool to fail and fracture when excessive pressure is put while cutting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up, it was confirmed that the patient had no further issues post-surgery and there were no additional actions taken.

• 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: 7740782
• Report Number: 1625507-2018-00039
• Device Sequence Number: 2542590
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: F2/8TA23S
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0215165392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/18/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other