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	02/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tool has been returned and analysis is pending.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.
Event or Problem Description
It was reported the dissecting tool fractured when initially turning the cranial flap.It was reported there were no patient symptoms or complications associated with this event.Report was escalated to a product event due to the reported malfunction.The surgeon replaced the tool with another tool of the same model and had no other issue.On follow up the physician and initial reporters contact information was provided.No additional information was available for the attachment that was used with the tool.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined the tool was used and fractured.Only the proximal portion of the tool was returned.Both cutting edges have impact defects and material donated by the metal object it struck.The impact defects and donor material are consistent with the tool running against a metal object.The most likely cause of the tool failure is the tool contacting a metal object during use at multiple locations along the cutting edge creating small notches.One of those notches caused a crack to propagate across the cross-section of the tool, leading to fracture.The tool geometry is optimized for high efficiency in dissecting bone and the cutting edge is sharp and thin; it is less effective on materials much harder than bone.The user manual includes the following general safety precaution: ¿visually inspect attachments and tools.Do not use bent or damaged tools.¿ if a tool contacts metallic objects, the user should re-inspect to confirm the tool is not damaged.We will continue to monitor this complaint type for trends.
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: 6463973
• Report Number: 1030489-2017-00763
• Device Sequence Number: 476900
• Product Code: HBE
• UDI-Device Identifier: 00643169766259
• UDI-Public: 00643169766259
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2017

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: 12/01/2021
• Device Model Number: F2/8TA23
• Device Catalogue Number: F2/8TA23
• Device Lot Number: H5325347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided; 04/11/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/02/2017; 10/02/2017
• 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