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

Model Number	T12MH20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
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 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.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after drilling the anterior cervical spine for approximately 2 minutes, the sound of the drill changed and the drill bit snapped off at the edge of the t12 guard.The piece of the drill bit was noted to be in the surgical wound and was removed.X-ray confirmed all pieces were removed.It was reported that there was no apparent harm to the patient.On follow up, it was reported that the broken piece of the tool was removed during the same surgery and the additional x-ray was performed only to confirm they had removed all of the tool bit that broke off.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the two pieces of the t12mh20 tool was returned inside the tt12c telescoping attachment (lot number 064606-03).The one piece of the tool could not be removed from the attachment.It was noted that the tool had heat related discoloration present on tube exit and tool.Fracture site is consistent with location of distal bearings in tt12c telescoping tube and the discoloration on tool is indicative of heat.The likely cause was identified that the distal bearings no longer supports the tool effectively.The tool contacted the non-rotating diameter of the tube exit and the excessive heat caused the tool to fracture.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.

• Brand Name: LEGEND 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: 7981103
• Report Number: 1625507-2018-00060
• Device Sequence Number: 16442714
• Product Code: HBE
• UDI-Device Identifier: 00643169766341
• UDI-Public: 00643169766341
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/04/2019

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: 10/16/2021
• Device Model Number: T12MH20
• Device Catalogue Number: T12MH20
• Device Lot Number: H5314916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 03/04/2019
• 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