MAUDE Adverse Event Report: STRYKER SPINE-US OASYS CROSS NUT TIGHTHENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48561075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cross nut tightener broke at the tip during final tightening.The broken fragment was retrieved.There are no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual analysis, material analysis, labelling review, product history review, complaint history review, risk assessment.The customer reported event was confirmed to have a fractured castle tooth that was removed immediately.The broken fragment was retrieved and surgery was successfully completed with no delay.Manufacturing records were reviewed and no manufacturing anomalies were reported and the instrument was found to be approximately 2.5 years old.Materials analysis was performed and found that "each castle tooth was found to have fractured from inside the castle in a mixed mode ductile with a small amount of cleavage.The hardness and material observed was consistent with what is specified on the print.No material or manufacturing defects were found." the possible causes for the fracture could be previous damage to the tightener or user error, intentional misuse, instrument/implant jams & user continues to apply force.
Event or Problem Description
It was reported that the cross nut tightener broke at the tip during final tightening.The broken fragment was retrieved.There are no adverse consequences to the patient.

• Brand Name: OASYS CROSS NUT TIGHTHENER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7714449
• Report Number: 0009617544-2018-00181
• Device Sequence Number: 19092767
• Product Code: LXH
• UDI-Device Identifier: 07613327271577
• UDI-Public: 07613327271577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/25/2018

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: 48561075
• Device Lot Number: 161151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1