MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM IMPACT BUMPER RT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	74011821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during implantation in a tka surgery, one (1) journey fem impact bumper rt broke.The procedure was resumed, without any delay, using a s+n backup device.No injury was reported as result of this issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during implantation in a tka surgery, two (2) journey fem impact bumper rt broke.The procedure was resumed, without any delay, using a s+n backup device.No injury was reported as result of this issue.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the bumper broke during implantation.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since the bumper broke external to patient due to normal wear and tear.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.Corrected data: b5.
Event or Problem Description
It was reported that, during implantation in a tka surgery, one (1) journey fem impact bumper rt broke external to the patient due to wear and tear.The procedure was resumed, without any delay, using a s+n backup device.No injury was reported as result of this issue.

• Brand Name: JOURNEY FEM IMPACT BUMPER RT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20013773
• Report Number: 1020279-2024-01620
• Device Sequence Number: 14546453
• Product Code: LXH
• UDI-Device Identifier: 03596010556455
• UDI-Public: 03596010556455
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 74011821
• Device Lot Number: 17FM02433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided; 08/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/22/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown