MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the xia 3 vitalium rod snapped while bending intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the rod was returned with a fracture on the distal end.The rod fractured at the laser marking.Neighboring laser marking was shown to have voids on it.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and one similar complaint was found.This device was manufactured in 2014, prior to implementation of a capa which identified that multiple conditions should be present to cause the intra-op fracture of vitallium rods.The rod has to have voids present in the laser marking, the rod is bent in an acute manner, and the laser marks must be placed on the convex side of the rod so to put the laser marking under tension.As voids were present on this device, the most likely root cause is related to the laser marking process which creates voids in rods.This device was manufactured before a process change was implemented for laser marking.
Event or Problem Description
It was reported that the xia 3 vitalium rod snapped while bending intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11148016
• Report Number: 3005525032-2021-00001
• Device Sequence Number: 19762924
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: 04546540608642
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 48232601
• Device Catalogue Number: 48232601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1