MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 VITALLIUM ROD WITH HEX PRECUT 6MM X 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rod broke upon first bend using french benders.This occurred outside of the patient's cavity.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported the rod broke upon first bend using french benders.This occurred outside of the patient's cavity.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Updated catalog number 48235480 from 48232601.
Event or Problem Description
It was reported the rod broke upon first bend using french benders.This occurred outside of the patient's cavity.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported the rod broke upon first bend using french benders.This occurred outside of the patient's cavity.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Visual inspection, product history review, complaint history review, labelling review, risk assessment.The reported event was confirmed via visual inspection.The rod was returned in 4 pieces.2 of the pieces were cut, the other 2 were fractured.The fracture occurred at the laser marking and voids were present on a neighboring laser mark under high magnification.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.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.

• Brand Name: XIA 3 VITALLIUM ROD WITH HEX PRECUT 6MM X 480MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7365137
• Report Number: 3005525032-2018-00009
• Device Sequence Number: 14031590
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 09/07/2018

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: 48232601
• Device Catalogue Number: 48235480
• Device Lot Number: GNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 02/24/2018
• Supplement Date Received by Manufacturer: 03/23/2018; 04/16/2018; 04/19/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 03/29/2018; 04/19/2018; 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1