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

Model Number 9734716

Device Problems Material Integrity Problem (2978); Mechanical Jam (2983)

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

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The clamp has been requested for return.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a spinal procedure.It was reported that the site was having issues with the drill stop not staying in the grooves of the drill bit and that it was loose.It was also noted that the spinous process clamp's washer or nut came out from the clamp when using the driver, and the site was not able to unscrew the clamp from the patient.The site was able to get the clamp off of the patient and no metal was found in the patient.There was no patient harm and the procedure was not delayed.

• Brand Name: SHORT SPINOUS PROCESS CLAMP
• 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: 10010307
• MDR Text Key: 189363976
• Report Number: 1723170-2020-01330
• 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
• Report Date: 04/29/2020

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
• Device Operator: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 151002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2015
• 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: 60 YR
• Patient Weight: 57