MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an es2 integrated blade screw tab fractured during distraction intra-operatively.
Event or Problem Description
It was reported that an es2 integrated blade screw tab fractured during distraction intra-operatively.The blocker was unable to be inserted into the screw correctly with the broken blade.There were no adverse consequences to the patient.The procedure was completed successfully, without surgical delay, by replacing the screw.
Additional Manufacturer Narrative
B.5 was updated to reflect additional information received.Visual inspection: visual inspection confirmed fracture of the blades on returned part.The area of dent formed by rod on screw shank head suggested that the blocker was over tightened and the tulip was at max polyaxial angle with the screw.Device history records were reviewed and no relevant manufacturing issues or similar complaints were identified.It was reported that blade broke during distraction and after breakage of blades, blocker was inserted.Per surgical technique, distraction is performed post blocker insertion.An exact root could not be determined.Probable root causes include: user error, user applies unintended cantilever force previously damaged or deformed mlcd assembly used mlcd assembly improperly seated, causes application of excess force on implant improper tolerancing of mlcd assembly to shafts.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9935854
• Report Number: 0009617544-2020-00057
• Device Sequence Number: 16768430
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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): 07/28/2020

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: Health Professional
• Device Model Number: 482802745
• Device Catalogue Number: 482802745
• Device Lot Number: 192378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR