MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 22MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552322
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head broke off the tulip screw during the case.The further reported that the construct had been locked down with the rod and the blocker.The surgeon then checked on x-ray and wanted to change the direction of the tulip head.When he tried to adjust it the head broke off the screw.The tulip head was removed with forceps and the surgeon was able to unwind the thread from the bone.No unintended metal was left in the patient.The bone was good quality and there were no other obvious issues.A new screw was inserted and the case was completed successfully with no lasting consequences for the patient.There was a 30 minute delay to surgery as a result of the reported event.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The screw tulip was confirmed separated based on visual examination.Manufacturing records for this product were reviewed and no anomalies were found.Potential root causes may be: user applies too much torsional force.User applies too much bending/cantilever force.
Event or Problem Description
It was reported that the head broke off the tulip screw during the case.The further reported that the construct had been locked down with the rod and the blocker.The surgeon then checked on x-ray and wanted to change the direction of the tulip head.When he tried to adjust it the head broke off the screw.The tulip head was removed with forceps and the surgeon was able to unwind the thread from the bone.No unintended metal was left in the patient.The bone was good quality and there were no other obvious issues.A new screw was inserted and the case was completed successfully with no lasting consequences for the patient.There was a 30 minute delay to surgery as a result of the reported event.

• Brand Name: OASYS 3.5 X 22MM 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: 6413754
• Report Number: 0009617544-2017-00099
• Device Sequence Number: 10840469
• Product Code: KWP
• UDI-Device Identifier: 04546540371720
• UDI-Public: (01)04546540371720
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K032394
• 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): 05/24/2017

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 Catalogue Number: 48552322
• Device Lot Number: 09C061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1