MAUDE Adverse Event Report: STRYKER SPINE-US OASYS TRANSVERSE CONNECTOR; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48551070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When tightening the transverse connector with torque wrench, the connector broke.The transverse connector was replaced with another same new one.No adverse consequences were reported.
Event or Problem Description
When tightening the transverse connector with torque wrench, the connector broke.The transverse connector was replaced with another same new one.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event was confirmed via communication with the representative.The device was not returned, therefore inspection could not be performed.Product history review was reviewed for the lot, and no relevant manufacturing issues were identified.Based on the surgical technique guide, the transverse connector is designed for added torsional rigidity of a bilateral rod construct.The clip-on design features a very low profile and does not add significantly to the height of the construct.The transverse bar is available in 40, 60, and 80mm lengths.The bar of the transverse connector can be cut so that the length can be adjusted to better match individual patient anatomy.The torque wrench must be used for final tightening of all connector set screws.The recommended torque value is the same as for the blockers: 3nm.The root cause of the reported event could not be determined since the device was not returned.Potential root causes include a difficult angle for insertion and/or previous damage to the clip during insertion.Device not returned.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7848016
• Report Number: 0009617544-2018-00213
• Device Sequence Number: 16761486
• Product Code: NKG
• UDI-Device Identifier: 04546540371607
• UDI-Public: 04546540371607
• Combination Product (Y/N): N
• 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): 10/04/2018

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 Catalogue Number: 48551070
• Device Lot Number: NAZ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR