MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 24MM PA SCREW MEDIAL; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48555424
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the oasys polyaxial screw the head and screw separated when the surgeon tried to pull the screw back slightly intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual: visual inspection was performed and confirmed tulip disengagement.No deformation is observed on the tulip head.Screw shank head is deformed, most likely from the screw shank removal process.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique guide (stg): tip: if the tip of a biased angle screw hits the bone before the screw is fully inserted, and the screw is unable to be driven in further, unthread the screwdriver sleeve from the tulip head while leaving the hex socket engaged with the screw to allow the screw head to spin freely and the bone screw to be driven in further.To minimize the potential for rigid locking and limiting the range of angulation, do not seat the screw head too tightly to the bone.Should the screw head become locked to the bone screw, use the screw head adjuster to break the lock.If needed, the screw may be backed out about half a turn to allow for the head to move freely.If it becomes necessary to remove a screw, begin by unthreading the bone screw with the hex portion of the polyaxial screwdriver, and then reattach the outer sleeve to complete the removal.For additional height adjustments to the screw, the poly adjustment driver can be used in place of the polyaxial screwdriver.This instrument has the same internal hex as the polyaxial screwdriver, but has no sleeve to impede vision.Initial report states that the screw tulip disengaged when the screw was pulled back.Upon follow up, it was found that the screw was inserter too deep and that excessive force may have been applied while trying to pull screw back.There was no damage to surrounding bone or tissue.The most likely cause of the reported event was determined to be deviation from the surgical technique.Stg states that screw removal shall be performed by "unthreading the bone screw with the hex portion of the polyaxial screwdriver, and then reattach the outer sleeve to complete the removal".It was reported that excessive force may have been applied while trying to pull the screw back, after it was inserted too far.
Event or Problem Description
It was reported that after inserting the oasys polyaxial screw the head and screw separated when the surgeon tried to pull the screw back slightly intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.

• Brand Name: OASYS 4.0 X 24MM PA SCREW MEDIAL
• 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: 12377683
• Report Number: 0009617544-2021-00142
• Device Sequence Number: 4090663
• Product Code: NKG
• UDI-Device Identifier: 04546540469625
• UDI-Public: 04546540469625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151755
• 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): 12/16/2021

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: 48555424
• Device Catalogue Number: 48555424
• Device Lot Number: 17A099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2017
• 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