MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AWL SHARP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was not received by the manufacturer on the date of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that the site had a damaged awl tip instrument.Through hammering on the navigated frame component instruments there has been damage to the awl tips in the ring where the ratcheting handle locks on to the awl.There was no patient present.

• Brand Name: AWL SHARP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8181438
• Report Number: 1723170-2018-06356
• Device Sequence Number: 1332543
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: No Information
• Device Model Number: 9734678
• Device Catalogue Number: 9734678
• Device Lot Number: 180412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1