MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 03821540

Device Problems Break (1069); Detachment Of Device Component (1104); Disconnection (1171)

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

Event Date 03/09/2018

Event Type  malfunction  

Event Description

It was reported that the tulip/ blades broke off the screw thread after final tightening.A new screw was used to complete the procedure.There was a total surgical delay of 20 to 30 minutes.There were no adverse health consequences to the patient.

Manufacturer Narrative

Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The device was returned in 2 pieces, with the tulip head disengaged from the screw shank.There was still a blocker threaded into the es2 screw blades.Deformation was found on the tulip locking ring and on the screw shank head.Manufacturing history was reviewed and no issues were identified.Conclusion: according to risk file, too much stress on the construct may cause stress concentration resulting in the failure of screw tab intra op.Root cause of the reported event could not be determined conclusively but potentially could be due to: user error, blocker not correctly aligned in tulip threads, too much torque applied (in excess of 12nm), counter torque tube not used, cantilever force applied during final tightening, rod seated poorly in tulip.

Event Description

It was reported that the tulip/ blades broke off the screw thread after final tightening.A new screw was used to complete the procedure.There was a total surgical delay of 20 to 30 minutes.There were no adverse health consequences to the patient.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7395061
• MDR Text Key: 104547925
• Report Number: 0009617544-2018-00075
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540149176
• UDI-Public: (01)04546540149176
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03821540
• Device Catalogue Number: 482804740
• Device Lot Number: 177356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1