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	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report inconclusive.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.Initial reporter phone no.: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the burr split in half during the procedure.On follow-up, it was confirmed that that there was no injury or harm to the patient but there was a minimal delay due to the burr replacement.It was also confirmed that there were no additional actions taken after surgery.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool was returned was used and broken.Only the tang end of the tool was returned, the distal portion was not returned.It was noted through microscopic examination of the tool that the fracture location and geometry is consistent with brittle fracture in bending.It was also noted that discoloration was present in circumferential bands near the exit.The likely cause is fatigue in plane bending due to the tool being pressed in a side load to dissect while it is not rotating causing the tool to fracture.It was also identified that the distal bearings of the af02 attachment used with the tool may be no longer supporting the tool adequately.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.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 street; fort worth TX 76137
• MDR Report Key: 8369674
• Report Number: 1625507-2019-00014
• Device Sequence Number: 1203966
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 09/05/2023
• Device Model Number: F2/8TA23S
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0216072841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1