MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 10.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482311550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled revision, the tulip of a xia serrato polyaxial screw broke off during screw removal.While replacing the serrato screw, the tulip of a xia 3 polyaxial screw also broke off.All pieces of the first screw were removed; however, the shaft of the second screw remains in the patient.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This report will represent the xia 3 screw.
Additional Manufacturer Narrative
Visual: visual inspection confirmed that the screw shank had fractured at the head of the shank.Tulip and screw head were returned.There are no wear or deformation marks on the tulip.There are multiple deformations on the shank head / screwdriver interface.The deformations were between the six point star locking holes that engage to the driver head.All 6 deformations were on the same side/direction radially, indicating deformation in a clockwise direction.The deformations on one side only, the clockwise direction, indicate over tightening of the screw or difficulty inserting the screw.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Xia 3 sgt was review and the following was found to be relevant: the screws may be inserted immediately after preparing and probing the pedicle.However, in most cases, tapping is recommended.With the pedicle pathway prepared, and the proper screw diameter and length determined, the screw can be inserted into the pedicle using the appropriate xia 3 screwdriver.The deformation on the screw head indicates excessive torque while inserting the screw in the clockwise direction.The most likely cause of reported event was determined to be over tightening of the screw.Attempting to insert a pelvic screw in an untapped or improperly prepared hole can cause high radial stresses which can cause the deformation observed.
Event or Problem Description
It was reported that during a scheduled revision, the tulip of a xia serrato polyaxial screw broke off during screw removal.While replacing the serrato screw, the tulip of a xia 3 polyaxial screw also broke off.All pieces of the first screw were removed; however, the shaft of the second screw remains in the patient.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This report will represent the xia 3 screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 10.5 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11194656
• Report Number: 3005525032-2021-00004
• Device Sequence Number: 19772132
• Product Code: NKB
• UDI-Device Identifier: 04546540598783
• UDI-Public: 04546540598783
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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 Model Number: 482311550
• Device Catalogue Number: 482311550
• Device Lot Number: B73348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1