MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 18MM PLATE SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48554318
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the silver screw broke upon insertion leaving the broken end in patient.It was reported that they were not able to remove it.It was also reported that the blue screw bent upon insertion.It was reported that lot numbers unknown, items removed from packaging to be sterilized in the set.It was reported that product reached patient; no apparent harm; probably inconvenient for patient and/or staff.
Additional Manufacturer Narrative
Lot# a3y.Method: visual inspection; device history review; complaint history review; risk assessment; results: materials analysis found "the fractured screw was found to have torsional ductile overload due to an applied torsional force during implantation.The chemistry of each submitted screw was consistent with the chemistry specified on the print.No material or manufacturing defects were found.Conclusion: the probable root cause of the screw breakage and deformation is not tapping to the full length of the intended screw.
Event or Problem Description
It was reported that; the silver screw broke upon insertion leaving the broken end in patient.It was reported that they were not able to remove it.It was also reported that the blue screw bent upon insertion.It was reported that lot numbers unknown, items removed from packaging to be sterilized in the set.It was reported that product reached patient; no apparent harm; probably inconvenient for patient and/or staff.

• Brand Name: OASYS 3.5 X 18MM PLATE 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: 5664997
• Report Number: 0009617544-2016-00195
• Device Sequence Number: 307241
• Product Code: KWP
• UDI-Device Identifier: 04546540371966
• UDI-Public: (01)04546540371966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2016

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: 48554318
• Device Lot Number: A3Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1