MAUDE Adverse Event Report: STRYKER SPINE-US XIA OFFSET CONNECTOR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03820101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery to harvest autogenous bone and to do anterior operation, the offset connector was broken when tightening.The offset connector was replaced with a new one and the surgery was completed.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.The customer reported event was confirmed via correspondence.The device was not returned for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Xia universal surgical technique informs users that offset connectors can be tightened lightly to ensure stability between the rod and offset connector.At least 1mm of the connector should be protruding out of the spinal screw to ensure proper use of the device.The final tightening is applied to the closure screw when used in conjunction with the offset connector which is most easily applied in conjunction with the polyaxial screw.When used with a monoaxial screw, the connector must be perpendicular to the screw head.The plausible root cause of the reported event could not be determined conclusively as the device was not returned.Incorrect alignment of the cross-connector onto the rod may have contributed to connector fracture.
Event or Problem Description
It was reported that during a revision surgery to harvest autogenous bone and to do anterior operation, the offset connector was broken when tightening.The offset connector was replaced with a new one and the surgery was completed.There are no reports of adverse health consequences to the patient.

• Brand Name: XIA OFFSET CONNECTOR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7444967
• Report Number: 3005525032-2018-00025
• Device Sequence Number: 2156355
• Product Code: NKB
• UDI-Device Identifier: 04546540148742
• UDI-Public: (01)04546540148742
• Combination Product (Y/N): N
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: No Information
• Device Model Number: 03820101
• Device Catalogue Number: 03820101
• Device Lot Number: 177467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR