MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO SMALL OFFSET CONNECTOR; IMPLANT-CONNECTOR

Catalog Number 48902010

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 10/10/2014

Event Type  malfunction  

Event Description

It was reported that during trio surgery (l4-5, plif), the strange noise was heard when surgeon was tightening the connector on right side l5.After that, the surgeon tried to reduction and tightening the connector on right side l4 but it is not successfully.Then, the surgeon checked the connector on right side l5 and found that the rod is out from the connector.The connector was exchanged to other new one, and the surgery was finished.There was 5 minutes delay in the surgery.After the surgery, sales rep confirmed the removed connector and he felt that the set screw do not move smoothly.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the returned connector set screw was rotated fully in both directions.The amount of effort required was more than expected.However the device was still fully functional as it could still be fully locked.The difficulty in rotating the set screw is likely the result of fully unthreading the screw past the idea area.This can cause damage to the threads, which can lead to difficulty when reinserting the set screw.However, additional factors including the surgeon technique, device positioning, and handling of the device prior to the event may have contributed to the issue.Conclusion: due to the multifactorial nature of the event, the root cause cannot be determined conclusively.

Event Description

It was reported that during trio surgery (l4-5, plif), the strange noise was heard when surgeon was tightening the connector on right side l5.After that, the surgeon tried to reduction and tightening the connector on right side l4 but it is not successfully.Then, the surgeon checked the connector on right side l5 and found that the rod is out from the connector.The connector was exchanged to other new one, and the surgery was finished.There was 5 minutes delay in the surgery.After the surgery, sales rep confirmed the removed connector and he felt that the set screw do not move smoothly.

• Brand Name: TRIO SMALL OFFSET CONNECTOR
• Type of Device: IMPLANT-CONNECTOR
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4232188
• MDR Text Key: 17588306
• Report Number: 0009617544-2014-00467
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48902010
• Device Lot Number: 143505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1