MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TITANIUM BONE ANCHOR; STYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	9735571
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a soft neuro tissue ablation procedure, the bone anchor bolt was damaged when being removed from the anatomy.It was reported that the wings on the bolt broke away from the stem of the unit.It was reported that the bolt was removed with a tool in the operating room (or).Additionally, the patient was being brought back to the or to wake up and exubate as part of the procedure workflow when the reported issue occurred.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.

• Brand Name: TITANIUM BONE ANCHOR
• Common Device Name: STYLET, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9323503
• Report Number: 1723170-2019-05623
• Device Sequence Number: 14100515
• Product Code: GAH
• UDI-Device Identifier: 00643169933415
• UDI-Public: 00643169933415
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 02/11/2021
• Device Model Number: 9735571
• Device Catalogue Number: 9735571
• Device Lot Number: 2019020249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 74