MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 32MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48555332
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the shaft of the screw deformed when it was inserted to the patient bone because the patient bone was so hard.The surgeon used other screw.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no anomalies were found.The stryker rep reported that the tap was not used to prepare the pedicle prior to implantation and that the bone quality was very hard.As instructed per the stg, "the preparation of the screw hole should follow the steps below, using the appropriate drill bit and tap conclusion: the root cause is not using the drill to prepare the screw hole as instructed in the stg.
Event or Problem Description
It was reported that; during surgery, the shaft of the screw deformed when it was inserted to the patient bone because the patient bone was so hard.The surgeon used other screw.

• Brand Name: OASYS 3.5 X 32MM PA SCREW MEDIAL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5710217
• Report Number: 0009617544-2016-00223
• Device Sequence Number: 190856
• Product Code: KWP
• UDI-Device Identifier: 04546540469571
• UDI-Public: (01)04546540469571
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

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: 48555332
• Device Lot Number: 132308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 67