MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150 MM DISPOSABLE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9733236
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A medtronic representative reported that after a spinal fusion procedure, the surgeon was removing a perc pin and bent the instrument.It was reported that the surgeon was removing the pin by grabbing the reference frame and puling on it.In the process, surgeon broke the pin on the perc pin which made using a slap hammer impossible.Surgeon the used pliers to remove the perc pin.The per pin was removed successfully without any patient harm but the instrument was bent.Medtronic representative informed surgeon not to remove the perc pin in the process and use of slap hammer.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient outcome.
Additional Manufacturer Narrative
Additional information: lot number and manufacture date provided.The suspect perc pin has been received by the manufacturer for evaluation.The reported issue is confirmed as the top of the pin is bent and twisted.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.

• Brand Name: 150 MM DISPOSABLE PIN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7125848
• Report Number: 1723170-2017-05187
• Device Sequence Number: 1210751
• Product Code: OLO
• UDI-Device Identifier: 00613994247865
• UDI-Public: 00613994247865
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: Physician
• Device Catalogue Number: 9733236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 95