MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 14MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552314
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned.
Event or Problem Description
Stryker representative reported that an oasys 3.5 x 14mm polyaxial screw became jammed after sterilization pre-operatively.Surgery was successfully completed with a replacement device.No adverse consequences or medical intervention were reported.
Event or Problem Description
Stryker representative reported that an oasys 3.5 x 14mm polyaxial screw became jammed after sterilization pre-operatively.Surgery was successfully completed with a replacement device.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed because the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The issue was found after sterilization.The most likely root cause is rough handling during cleaning / sterilization that most likely caused the tulip to overextend and jam onto the shank.
Event or Problem Description
Stryker representative reported that an oasys 3.5 x 14mm polyaxial screw became jammed after sterilization pre-operatively.Surgery was successfully completed with a replacement device.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual: visual inspection confirmed that the tulip head was jammed and had no degree of movement on shank head.There is excessive wear on shank bulb head for an unused product as well as foreign material seen on the threads of shank.It is also observed that there is foreign material on the threading of the screw, indicating that the device may have been improperly cleaned/sterilized, and/or that the device was used during a procedure.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Oasys surgical technique: one of the key features of the biased angle polyaxial screw is the offset angle of the screw head, which allows for combined divergent screw angulation of110° (or 55° in one direction).The high degree of angulation promotes screw placement at an optimal anatomic position, helping to simplify the surgical procedure by minimizing the need for rod contouring due to linear placement of the screw heads.There are five types of polyaxial screws available in the oasys system.As it was reported that this event occurred after sterilization, but before the procedure, the most likely root cause is rough handling during cleaning/sterilization.Rough handling most likely caused the tulip to overextend and jam onto the shank.Foreign material on the screw threads also indicates that a potential root cause may have been that excessive force was applied to screw during screw insertion.

• Brand Name: OASYS 3.5 X 14MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9924280
• Report Number: 0009617544-2020-00055
• Device Sequence Number: 3436224
• Product Code: NKG
• UDI-Device Identifier: 04546540371683
• UDI-Public: 04546540371683
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 08/04/2021

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: 48552314
• Device Catalogue Number: 48552314
• Device Lot Number: 18A242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 07/25/2020; 07/07/2021
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 08/20/2020; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1