MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) AWL TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734404
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field representative reported that the tip of the awl tip instrument was bent, however, the part was not returned to manufacturer for analysis, therefore, no findings are possible.Replacement of the instrument resolved the issue.No further issues were reported.Part not returned.
Event or Problem Description
A medtronic representative reported that while in a spinal fusion procedure, they discovered a bent tip on the awl tip instrument.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
The hardware investigation of the returned awl tip found that the reported event was related to a physical damage issue.As reported, the tip of the awl was visibly bent.There are also impact marks at the back end of the instrument.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: AWL TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6409787
• Report Number: 1723170-2017-01232
• Device Sequence Number: 19001571
• Product Code: OLO
• UDI-Device Identifier: 00613994736055
• UDI-Public: 00613994736055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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 Catalogue Number: 9734404
• Device Lot Number: 150122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1