MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ALIGNMENT TUBE; GUIDE, SURGICAL, INSTRUMENT

Model Number	74014461
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set-up of total knee arthroplasty surgery, a journey ii alignment tube was noticed to be broken.Surgery was performed, without any delay, with a smith & nephew back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the jrny ii alignment tube is broken.The spring on the instruments appears to be damaged which causes it to not properly function.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.G2: report source update.D8 and d9: device returned.

• Brand Name: JRNY II ALIGNMENT TUBE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12171081
• Report Number: 1020279-2021-05970
• Device Sequence Number: 935303
• Product Code: FZX
• UDI-Device Identifier: 00885556237892
• UDI-Public: 00885556237892
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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 Model Number: 74014461
• Device Catalogue Number: 74014461
• Device Lot Number: 17GBG0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1