MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318590
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that the head of a xia 3 titanium polyaxial screw 8.5 x 90mm broke off intra-operatively during implantation.Surgery was successfully completed with a smaller diameter screw (7.5x90).There was no reported adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection found the screw tulip was returned jammed onto the xia 3 screwdriver.The screw was fractured at the bulb, the main shaft was returned, which was cut and shaved in an effort to remove it from the patient.The tulip was able to be removed with significant force applied.Tulip was not misaligned with the screwdriver.Material analysis was done on a similar complaint; the submitted polyaxial screw was found to have fractured in a mode of ductile overload due to an applied torsional force.The elemental constituents met the print requirements.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: the xia 3 monoaxial and polyaxial titanium self-tapping screws have a cutting flute to allow a surgeon to eliminate the tapping step.The screws may be inserted immediately after preparing and probing the pedicle.However, in most cases, tapping is recommended.Based on the results from the similar material analysis, and the fact that the tulip was returned jammed onto the screwdriver tip along with the fractured screwdriver in a similar complaint, the most likely root cause is excessive torsional force applied.It was reported that excessive force was applied due to the screw not easily advancing, this can occur due to inadequate screw hole preparation and/or undertapping.
Event or Problem Description
Physician reported that the head of a xia 3 titanium polyaxial screw 8.5 x 90mm broke off intra-operatively during implantation.Surgery was successfully completed with a smaller diameter screw (7.5x90).There was no reported adverse consequence to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9296355
• Report Number: 3005525032-2019-00086
• Device Sequence Number: 13893973
• Product Code: NKB
• UDI-Device Identifier: 04546540598660
• UDI-Public: 04546540598660
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: Health Professional
• Device Catalogue Number: 482318590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1