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

Catalog Number 48902015

Device Problem Difficult to Remove (1528)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported that during extraction of trio trauma, a set screw of connector can no longer loose in the middle.However it was finally extracted.

Event Description

It was reported that during extraction of trio trauma, a set screw of connector can no longer loose in the middle.However, it was finally extracted.

Manufacturer Narrative

Method: device history review; visual inspection; functional inspection; complaint history review; risk assessment; labeling review; additional document review results: the connector was received with a jammed set with visibly worn hex corners.The worn nature of the hex suggests that the corresponding hex tip was forcibly rotated while the set screw remained stationary, which confirms that the set screw was jammed in the offset connector.No manufacturing issues were identified during manufacturing record review.Conclusion: because the related connector was implanted in the body for some time, it is highly likely that the jamming is due to galling of the connector and biological particles lodged between the offset connector and set screw threads.

• Brand Name: TRIO LX SMALL 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: 4062537
• MDR Text Key: 4814882
• Report Number: 0009617544-2014-00390
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070368
• 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: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48902015
• Device Lot Number: 138792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2013
• 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
• Patient Age: 42 YR