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

Model Number	03821540
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7395061
• Report Number: 0009617544-2018-00075
• Device Sequence Number: 69643
• Product Code: NKB
• UDI-Device Identifier: 04546540149176
• UDI-Public: (01)04546540149176
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1