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

Model Number	F2/8TA23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined the tool was used and broken.The distal portion was not returned.Microscopic examination revealed impact defects (dents) on cutting edge at fracture site.Shaving of donor material on cutting edge proximal to fracture site.Fracture face is mostly planar and perpendicular to axis of rotation, with a ¿riser¿ on one side.Shape of fracture is consistent with initiation on edge with impact defect.Impact created when tool contacted a metallic object while rotating.The likely cause was identified as tool contacted a metallic object while rotating and an impact defect was created in at least two locations.The deeper defect found on the returned portion of the tool provided a crack initiation point and the tool fractured during use with normal loads.The user manual contains the following warning ¿slender design for precise dissection with minimal bone loss.For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etc.,¿ which does not include cutting metal.We will continue to monitor this complaint type for trends.
Event or Problem Description
It was reported that dissecting tool broke during a procedure.X-ray was completed to retrieve the broken piece.There was no patient impact.On follow up the initial reporters name was provided.The surgical procedure was a craniotomy for subdural.It was confirmed there was a 30 minute delay in the procedure to retrieve a new tool and drill, and x-ray the patient to retrieve the broken tool.Some patient information was also provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MIDAS REX® 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: 6676659
• Report Number: 1030489-2017-01646
• Device Sequence Number: 1881990
• Product Code: HBE
• UDI-Device Identifier: 00643169766259
• UDI-Public: 00643169766259
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 03/07/2022
• Device Model Number: F2/8TA23
• Device Catalogue Number: F2/8TA23
• Device Lot Number: H5344394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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, UNKNOWN SN
• Patient Age: 74 YR