MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 20; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screws stripped during the procedure.
Additional Manufacturer Narrative
Visual analysis, functional analysis, device history review, complaint history review, risk assessment.The screw was not confirmed to have any securing mechanism deformation per the functional testing where the polyaxial screw was confirmed to be able to be firmly attached to a polyaxial screwdriver.Manufacturing records for this product were reviewed and no incidents were found.The stryker rep reported that the pa screwdriver was locked on the screw as instructed in the stg.When the locking screwdriver is firmly locked to the screw, there is no movement of the pa screw on the tip.The stg also states that "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" visual and functional tests performed did not confirm the event, so no product problem was found.The probable root causes are not using the optional sleeve for the polyaxial screwdriver and/or not having the screw firmly attached to the screwdriver.
Event or Problem Description
It was reported that the screws stripped during the procedure.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 20
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5821869
• Report Number: 0009617544-2016-00306
• Device Sequence Number: 1227333
• Product Code: KWP
• UDI-Device Identifier: 04546540596420
• UDI-Public: (01)04546540596420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• 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): 07/02/2016

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: No Information
• Device Catalogue Number: 48558520
• Device Lot Number: 137452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1