MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERCUTANEOUS REFERENCE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733236
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a oblique lumbar interbody fusion (olif) procedure.It was reported that the percutaneous pin was placed and upon attempting to connect the reference frame, the locking pin fell out of the pin, causing a removal of the pin and re-insertion of a new pin.There was no delay in the procedure and no impact on patient outcome.
Additional Manufacturer Narrative
The pin 9733236 150mm sterile perc ref (lot# 180806) was returned for analysis.Analysis found that the returned perc pin was missing the cross pin.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCUTANEOUS REFERENCE PIN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8935403
• Report Number: 1723170-2019-04649
• Device Sequence Number: 2000820
• Product Code: OLO
• UDI-Device Identifier: 00613994247865
• UDI-Public: 00613994247865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: 9733236
• Device Catalogue Number: 9733236
• Device Lot Number: 180806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 66