MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48558528
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery while placing in a t1 pedicle screw with a custom ratcheting screw driver, an oasys screw tulip head broke off.The screw holes were prepared with a gear shift and a tap and the patient had good bone quality.The surgeon used a vice grip to remove the screw and all broken fragments were retrieved.The same size screw used was to successfully complete the surgery.There was 40 minutes surgical delay.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection showed the tulip was confirmed separated from the screw shank.Manufacturing records for this product were reviewed and no anomalies were found.Conclusion: the probable root cause is not determined.
Event or Problem Description
It was reported that; during surgery while placing in a t1 pedicle screw with a custom ratcheting screw driver, an oasys screw tulip head broke off.The screw holes were prepared with a gear shift and a tap and the patient had good bone quality.The surgeon used a vice grip to remove the screw and all broken fragments were retrieved.The same size screw used was to successfully complete the surgery.There was 40 minutes surgical delay.There were no adverse consequences to the patient.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6809365
• Report Number: 0009617544-2017-00326
• Device Sequence Number: 1760274
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 10/27/2017

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 Model Number: 48558528
• Device Catalogue Number: 48558528
• Device Lot Number: 171604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR