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

Catalog Number	9734724
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested.Replacement double process short clamp shipped to site (b)(6) medtronic investigation of returned suspect double process short clamp finds that as reported, the retainer ring has been pulled from the tip of the adjustment screw and is missing.The ring is pulled from the screw not from over-tightening but from turning the screw further than the design will allow to remove the clamp.Without the retainer ring, the adjustment screw would be able to set the clamp but not remove it.Reported problem was confirmed.Hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.
Event or Problem Description
A medtronic representative reported that, while in a spine procedure, the site's double process short clamp had a broken washer.Surgeon was attempting to place the clamp on the patient when the washer broke.Surgeon removed the broken washer from the patient and used a second double process short clamp from another tray to continue the procedure.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome reported.

• 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: 6549307
• Report Number: 1723170-2017-01817
• Device Sequence Number: 16396458
• Product Code: OLO
• UDI-Device Identifier: 00643169936461
• UDI-Public: 00643169936461
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• 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: Physician
• Device Catalogue Number: 9734724
• Device Lot Number: 150827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial 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
• Patient Age: 63 YR
• Patient Weight: 79