MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG LEGEND DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	F2/8TA23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	05/25/2017
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A medwatch form ((b)(4)) was received with the following details: "when this side-cutting bur was being used to remove the bone flap during a craniotomy, the top portion about 2cm of the bur broke off and flew out of view.The remaining piece was removed from the midas rex attachment and replaced, and the craniotomy proceeded uneventfully.The missing part of the bur could not be found after searching the field and the surrounding floor, so during the case, c arm was called into the room.The broken piece was located in the operative field by c arm visualization." on follow up the event date and physician's information were provided.It was reported that this was the initial use of the tool.There was no significant delay in the procedure while changing the bur.It was confirmed that the broken off piece was found by the c-arm visualization on the operative field while the patient was present.Additional patient information was provided.It was also reported the patient had expired since the procedure for reasons unrelated to this event.Partial concomitant information was provided for the af02 attachment.

• Brand Name: LEGEND DISSECTING TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6807019
• Report Number: 1030489-2017-01938
• Device Sequence Number: 13477951
• Product Code: HBE
• UDI-Device Identifier: 00643169766259
• UDI-Public: 00643169766259
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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: 11/22/2021
• Device Model Number: F2/8TA23
• Device Catalogue Number: F2/8TA23
• Device Lot Number: H5322925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AF02 ATTACHMENT, SN UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Weight: 70