MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48558532
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip of an oasys polyaxial screw did not engage with the oasys polyaxial screwdrivers during repositioning at c7 intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Event or Problem Description
It was reported that the tulip of an oasys polyaxial screw did not engage with the oasys polyaxial screwdrivers during repositioning at c7 intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Inspection of the screw head shows high levels of deformation.Corners of hex on the head of screw are rounded to the point where the hex is smooth, and does not have noticeable corners.Deformation observed indicates stripping of the screw.Causes of this may be due to excessive force and/or worn/deformed driver tips.The two screw drivers associated with this event were inspected.The hex tips of both drivers were found to be deformed/worn.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From the oasys surgical technique guide: 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.There is an optional outer sleeve that may be used on the polyaxial screwdriver.This sleeve allows you to hold the shaft of the polyaxial screwdriver for better stabilization without having the polyaxial screw disengage from the polyaxial screwdriver.The sleeve can be placed on the polyaxial screwdriver by holding in the button while sliding the sleeve over the shaft.The most likely cause of the reported event was determined to be due to worn screw driver tips.Investigation on the associated screwdriver found the device to be 9 years old and have significant wear on the hex tip.This deformation may cause stripping/slippage on the screw head.Once the head of the screw is deformed it may become more difficult for any driver to engage with the screw head, making it difficult to properly remove the screw.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32
• 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: 12378326
• Report Number: 0009617544-2021-00143
• Device Sequence Number: 4090664
• Product Code: NKG
• UDI-Device Identifier: 04546540596451
• UDI-Public: 04546540596451
• 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): 12/10/2021

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: 48558532
• Device Catalogue Number: 48558532
• Device Lot Number: 130375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 11/13/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2013
• 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