MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP, SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734716

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a procedure.It was reported that during the case the short spinous process clamp broke.The site stated that the washers were falling out.There was no surgical delay due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that this issue occurred during a posterior lumbar fusion procedure.

Manufacturer Narrative

Additional information: patient information has been updated.Device evaluation: the short spinous process clamp was returned to the manufacturer for analysis.Through visual/physical examination and functional testing, the reported issue was able to be duplicated.As reported, the retainer ring had been pulled from the tip of the adjustment screw.The screw would close the clamp but not release it.It was determined that there was a physical damage failure with the returned clamp.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that, in order to proceed with the case, the surgeon used a long clamp and continued with navigation.There was a delay of approximately 10-15 minutes to the case.

• Brand Name: CLAMP, SPINOUS PROCESS SHORT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8177125
• MDR Text Key: 130892404
• Report Number: 1723170-2018-06342
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 160707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 101