MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48902015

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It was reported that during remove surgery (fracture part (th12) is the bone union); the surgeon removed the left side implants.And the surgeon tried to loosen set screw of the right side offset connector.When the surgeon loosened the set screw (th11), the hex of set screw was deformed.Although the surgeon used trio trauma torque wrench connector, the set screw was not loosened.Therefore, the surgeon added wound of patient.And the surgeon cut the rod and removed the rod and the offset connector.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.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.Conclusion: because the related connector was implanted in the body for some time it is likely that the jamming is due to biological particles lodged between the offset connector.

Event Description

It was reported that during remove surgery (fracture part (th12) is the bone union); the surgeon removed the left side implants.And the surgeon tried to loosen set screw of the right side offset connector.When the surgeon loosened the set screw (th11), the hex of set screw was deformed.Although the surgeon used trio trauma torque wrench connector, the set screw was not loosened.Therefore the surgeon added wound of patient.And the surgeon cut the rod and removed the rod and the offset connector.

• Brand Name: TRIO LX SMALL CONNECTOR
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4796510
• MDR Text Key: 19092748
• Report Number: 0009617544-2015-00240
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48902015
• Device Lot Number: 139881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2013
• 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 Outcome(s): Required Intervention