MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 5.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 03829545

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 12/01/2017

Event Type  malfunction  

Event Description

It was reported that; the patient was placed in the prone position, the routine surgical disinfection with the towel was performed.The surgical field exposure was fully clear, and regular open cone.The road opener took the pin, pin was set and the position of the perspective was good.Screw was implanted.After the perspective, second screw was implanted.The appropriate length was selected and the screw plug was inserted.The screw was broken and the nail broke.

Manufacturer Narrative

Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The screw was returned with the blocker still inserted in the tulip head.The blocker was fractured and could not be removed.The tulip head was overextended on the screw shank and polyaxiality was lost.Manufacturing history was reviewed and no issues were identified.No additional information was received regarding what torque was applied to the blocker or what instrument was used for final tightening.According to the surgical technique, the xia torque wrench and anti torque key must be used to apply the recommended 12nm of torque.Overtorqueing of the device can cause the blocker to fracture and the tulip to overextend.This was confirmed with the results of the material analysis for the blocker associated with this event.It was found that the blocker fractured at the point of contact with the rod.This would happen if the blocker was overtightened down onto the rod past 12 nm.Conclusion: the root cause is multifactorial as it is unknown what instrument was used to tighten down the blocker and what torque it was tightened down to, but excessive overtightening was the cause of the overextended tulip head.

Event Description

It was reported that; the patient was placed in the prone position, the routine surgical disinfection with the towel was performed.The surgical field exposure was fully clear, and regular open cone.The road opener took the pin, pin was set and the position of the perspective was good.Screw was implantable.After the perspective, second screw was implanted.The appropriate length was selected and the screw plug was inserted.The screw was broken and the nail broke.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 5.5 X 45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7180298
• MDR Text Key: 97093404
• Report Number: 0009617544-2018-00006
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07613154407835
• UDI-Public: (01)07613154407835
• Combination Product (y/n): N
• PMA/PMN Number: K061854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03829545
• Device Catalogue Number: 03829545
• Device Lot Number: 170132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1