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

Model Number	10BA30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a spine surgery, our tool broke off and the surgeon possibly hit the existing cervical cage.No impact was reported.No additional information was provided regarding patient status.Additional information about the event is being followed up from the facility contact person.
Additional Manufacturer Narrative
Further analysis determined the presence of titanium near and at location of tool fracture.This is an indication that the 10ba30 tool ran against a titanium surgical instrument during the procedure.Per ifu, "legend dissecting tools are intended for cutting bone and biomaterials." this does not preclude materials harder than bone.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the 10ba30 tool returned was used and broken.The tang end of the tool was received while the head end of the tool was not received.It was noted that there was discoloration present near the fracture site and indicates that the tool ran against an unknown material after fracture.The likely cause was identified as the tool ran against other metal devices, causing the device to fracture.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.
Additional Manufacturer Narrative
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 facility has no other information regarding the patient's current condition and the extent of injury experienced during the procedure.

• Brand Name: LEGEND 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: 8054495
• Report Number: 1625507-2018-00069
• Device Sequence Number: 1484831
• Product Code: HBE
• UDI-Device Identifier: 00643169757370
• UDI-Public: 00643169757370
• Combination Product (Y/N): N
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2019

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: 10/01/2022
• Device Model Number: 10BA30
• Device Catalogue Number: 10BA30
• Device Lot Number: 0214100455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 02/15/2019; 03/01/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 02/01/2019; 02/15/2019; 03/26/2019
• 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
• Patient Age: 70 YR