MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT TRL RT SZ 5-6 9M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,

Model Number	74033651
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, after trialing, the posterior medial aspect of the jrny ii cr isrt trl rt sz 5-6 9m snapped off when was being removed.All pieces were removed from patient.Surgery resumed, without any delay, with a back-up device.Patient was not harmed.No further complications reported.
Additional Manufacturer Narrative
H3, h6.The associated complaint device was returned and evaluated.A visual inspection of the insert trial confirms a piece of the device broke off.The broken pieces was not returned for evaluation.Also the visual confirms several burrs and gouges in the plastic.The insert trail exhibits signs of significant use and wear.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the information provided, all the broken pieces were removed from inside of the patient.According to the report, the surgeon resumed the procedure without any delay using a back-up device.Per subsequent e-mail, the surgeon reported he has seen the patient after the surgery and there were no further complaints regarding s&n implants.Therefore, since there was no alleged harm to the patient or other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II CR ISRT TRL RT SZ 5-6 9M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,
• 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: 14074210
• Report Number: 1020279-2022-01763
• Device Sequence Number: 16806023
• Product Code: JWH
• UDI-Device Identifier: 00885556421888
• UDI-Public: 00885556421888
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74033651
• Device Catalogue Number: 74033651
• Device Lot Number: 13FAP2184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown