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

Catalog Number	48232601
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	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rod snapped in half when used with a french bender.Per email conversation all fragments were removed and surgery completed successfully with different rod.No adverse consequences to the patient were reported.This is complaint is reportable as malfunction due to potential of fragment remaining.
Event or Problem Description
It was reported that the rod snapped in half when used with a french bender.Per email conversation all fragments were removed and surgery completed successfully with different rod.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the rep.The rod was returned in 3 pieces.The smaller two sections were fractured from each other.The longer segment was cut away from the rest of the rod.The rod fractured at the laser marking.The laser marking was shown to have voids on it.Capa was opened to investigate rod fractures and add updates to the manufacturing process to reduce the amount rod fractures.The major contributing root cause related to the issue are the voids that are created in the part during the laser marking process.Manufacturing process updated to no longer create voids.Conclusion: the root cause of the reported event is voids created during the laser marking process.

• 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: 7987122
• Report Number: 3005525032-2018-00068
• Device Sequence Number: 13873516
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: 04546540608642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: Health Professional
• Device Catalogue Number: 48232601
• Device Lot Number: HVP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1