MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP 9734724 DOUBLE PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734724
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Instrument was returned to the manufacturer for analysis.Evaluation is anticipated, but not yet completed.
Event or Problem Description
Information was received regarding an instrument that was used during a spinal fusion procedure.It was reported that during the case, the healthcare provider (hcp) was trying to open the instrument to fit it on the spinous process and backed the screw out too far.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.No further information was provided.
Additional Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
Additional Manufacturer Narrative
The damaged clamp was returned to the manufacturer for further analysis.Functional and visual tests were conducted on the part.Testing was able to confirm the reported issue and found the retainer ring had broken off which did not allow the clamp to properly close.No further action required.

• Brand Name: CLAMP 9734724 DOUBLE PROCESS SHORT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7457614
• Report Number: 1723170-2018-01727
• Device Sequence Number: 1067618
• Product Code: OLO
• UDI-Device Identifier: 00643169936461
• UDI-Public: 00643169936461
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 08/06/2018

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: 9734724
• Device Lot Number: 150815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 06/01/2018; 08/06/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 06/04/2018; 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 77