MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734715

Device Problem Material Deformation (2976)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

Udi not available for this system at time of filing.Device manufacturing date is not available at this time.No parts have returned to the manufacturer for evaluation.Part not returned for analysis.

Event Description

A site representative reported that, while in a spinal fusion procedure the spine clamp was damaged and broke.The physician had to remove the spinous process due to the damaged clamp.At that point, the physician aborted imaging and navigation and used a c-arm to successfully complete the case.There was an approximate 10 minute delay to the procedure as a result of this issue.No additional information was provided.

Manufacturer Narrative

Part udi is now provided in appropriate field.Part manufacture date is now provided in appropriate field.Analysis of the returned reported clamp confirmed physical damage as the retainer ring was pulled from the tip of the adjustment screw and was missing.As is, the adjustment screw would be able to close the clamp but not open it.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.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: sam saleh ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7215779
• MDR Text Key: 98094299
• Report Number: 1723170-2018-00316
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734715
• Device Lot Number: 150123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73