MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734723 DOUBLE PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734723
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing date was unavailable at the time of filing.The device has been returned but analysis was no yet completed at the time 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 device being used for a sacroiliac and thoracolumbar procedure.It was reported that the spine clamp was stuck on the spinal process and had to be pried off to remove.The washer separated, which caused the clamp to not open.There was no reported impact to patient outcome and a reported delay of less than 1 hour.
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The clamp was found to be missing the retention ring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLAMP 9734723 DOUBLE PROCESS TALL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8035042
• Report Number: 1723170-2018-05477
• Device Sequence Number: 16499150
• Product Code: OLO
• UDI-Device Identifier: 00643169936331
• UDI-Public: 00643169936331
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 02/20/2019

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: No Information
• Device Model Number: 9734723
• Device Catalogue Number: 9734723
• Device Lot Number: 150815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 91