MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 20; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48558320
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital did not return device.
Event or Problem Description
It was reported that when the surgeon placed the locking cap over the oasys polyaxial (non biased) screw, it broke at the threaded portion.The screw was, "taken out after great difficulty and replaced" resulting in a one hour delay.
Additional Manufacturer Narrative
Visual inspection of the returned product confirmed that the tulip was separated from the screw shank.Product and complaint history review was performed on the provided lot number and no production issues or prior occurrences were found.Per surgical technique: 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.Aligning the polyaxial screwdriver in the same axis as the screw hole facilitates screw insertion.The locking screwdriver provides another option for screw insertion.The driver attaches to the screw in the same manner as the standard polyaxial screwdriver.Once locked, the locking driver assembly becomes monolithic.The screw can only be loosened by rotating the driver counterclockwise.This instrument helps reduce any risk of accidental disengagement of the driver from the screw during screw insertion.The root cause could not be established as the device was not returned.
Event or Problem Description
Physician reported that the tulip head of an oasys screw became detached during implantation.The screw was, "taken out after great difficulty and replaced" resulting in a one hour delay.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 20
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8864152
• Report Number: 0009617544-2019-00093
• Device Sequence Number: 13530865
• Product Code: NKG
• UDI-Device Identifier: 04546540596352
• UDI-Public: 04546540596352
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/20/2019

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 Catalogue Number: 48558320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1