MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 30MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552430
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw can not be screwed into,change another new one.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the reported event was not confirmed as the returned polyaxial screw was able to be firmly connected to a polyaxial screwdriver.As instructed per the stg, "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.Conclusion: the plausible root cause is the user.
Event or Problem Description
It was reported that the screw can not be screwed into,change another new one.

• Brand Name: OASYS 4.0 X 30MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5645145
• Report Number: 0009617544-2016-00176
• Device Sequence Number: 293168
• Product Code: KWP
• UDI-Device Identifier: 04546540371836
• UDI-Public: (01)04546540371836
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2016

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: 48552430
• Device Lot Number: 13E662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR