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

Catalog Number	9734724
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A site representative reported that during spinal fusion cervical procedure, clamp had a loose screw.The procedure was completed with the use of navigation.There was no delay to procedure.No information was provided on patient impact.
Additional Manufacturer Narrative
The suspect clamp was returned to the manufacturer for evaluation.Visual inspection found that the retainer ring was removed from the adjustment screw.This results in the clamp being able to tighten but not open.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.This device is included in medical device field correction notification, "difficulty in opening and removing spinous process clamps" (june 2017).The revised instructions for use (ifu) were provided with the notification.
Additional Manufacturer Narrative
Correction: unique device identification (udi) updated to proper value.

• 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: 7046436
• Report Number: 1723170-2017-04773
• Device Sequence Number: 13478209
• Product Code: OLO
• UDI-Device Identifier: 00643169936461
• UDI-Public: 00643169936461
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2018

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: 150827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 01/04/2018; 01/25/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/24/2018; 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FCA 2017-06-22
• Patient Sequence Number: 1