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

Model Number	F1/8TA15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that both tools returned has similar fracture locations near the fluted end portion.The likely cause was identified as the fracture location, orientation and surface texture is consistent with tools breaking when a side load was applied on the tool during use.Bending stress caused the tool to bend and break.Tools were most likely not rotating when each broke.The device user manual warnings section includes 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 two of the same type of tools were broken when a suture hole of craniotomy line was being created.It was reported that there was no patient impact.No further information was obtained upon follow up.

• Brand Name: LEGEND TAPERED DISSECTING TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX 76137
• MDR Report Key: 7661706
• Report Number: 1625507-2018-00032
• Device Sequence Number: 2629955
• Product Code: HBE
• UDI-Device Identifier: 00643169766235
• UDI-Public: 00643169766235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 01/03/2023
• Device Model Number: F1/8TA15
• Device Catalogue Number: F1/8TA15
• Device Lot Number: 0214621481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1