MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48558528
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative screw insertion, the tulip of an oasys screw disengaged from the screw shank.In order to remove the screw shank the patient's bone had to be "drilled away" from around the implantation site.The procedure was completed successfully with a five minute surgical delay.
Additional Manufacturer Narrative
A visual inspection was performed on the device and the reported issue of tulip disengagement was confirmed.No wear, deformation, or fracture is observed on the tulip.The screw shank is damaged due to drilling to remove the shank from bone.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for the lot and subject catalog number and no adverse trends were observed.Oasys view and guide surgical technique was reviewed: ¿ a polyaxial screw is attached to the polyaxial screwdriver by placing the hex head socket over the bone screw and threading the end of the outer sleeve into the polyaxial screw head for stable fixation.Prior to screw implantation, use the gauges incorporated into the implant tray to verify the screw dimensions.Aligning the polyaxial screwdriver in the same axis as the screw hole facilitates screw insertion.Once the screw has been inserted, the polyaxial screwdriver can be removed by unthreading the end of the sleeve from the screw.¿ ¿ use of the locking screwdriver helps reduce any risk of accidental disengagement of the driver from the screw during screw insertion.¿ as the screw shank is damaged due to drilling to remove the shank from bone, it is unable to determine what damage is from the removal process versus insertion and a definitive root cause for the tulip disengagement could not be determined.
Event or Problem Description
It was reported that during intra-operative screw insertion, the tulip of an oasys screw disengaged from the screw shank.In order to remove the screw shank the patient's bone had to be "drilled away" from around the implantation site.The procedure was completed successfully with a five minute surgical delay.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: POSTERIOR CERVICAL 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: 14003057
• Report Number: 0009617544-2022-00040
• Device Sequence Number: 20106228
• Product Code: NKG
• UDI-Device Identifier: 04546540596444
• UDI-Public: 04546540596444
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 48558528
• Device Catalogue Number: 48558528
• Device Lot Number: 210189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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