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 Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital disposed of device.
Event or Problem Description
It was reported that the tab of an es2 blade screw was damaged intra-operatively.There were no adverse consequences to the patient or reported surgical delays.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was disposed of by the customer.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that during insertion, the tab of an es2 blade screw was fractured intra-operatively.Per additional correspondence, the tab fractured at welding during screw insertion, no broken fragments were left in patient, it is unknown if the screw was inserted at an extreme angle or if excess force was applied.It was reported that the issue occurred as a c ring was not used during the surgery.The es2 surgical technique was reviewed: ¿ring can be loaded onto the blades to help maintain their open position, once the screw is inserted and the polyaxial screwdriver and dilator 3 are removed.Rod template is placed into the notches on the ring with the rings at the same level and the blades held upright and parallel.Position the rings along the blades of the screws at the same hole level (1-7).With the rings at the same level and the blades held upright and parallel, place the rod template into the notches on the rings.¿ it is possible that in the absence of ring, an excess cantilever force was applied onto the tab leading to tab fracture.Difficult angle may have also contributed to the event.However, since the device was not returned and lack of information, an exact cause of the reported event could not be determined.
Event or Problem Description
It was reported that the tab of an es2 blade screw was damaged intra-operatively.There were no adverse consequences to the patient or reported surgical delays.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12642115
• Report Number: 0009617544-2021-00206
• Device Sequence Number: 4343903
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/26/2022

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: 204222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown