MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI FEMORALTRIAL HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	74016424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the knob of the jrny ii uni femoraltrial holder that tightens to implant snapped ((b)(4)) and the bumper cracked upon impaction ((b)(4)).These events occurred during use, while inside the patient.The procedure was completed using the same devices.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
The device, used in treatment, were returned for evaluation.A visual inspection of the returned jrny ii uni femoraltrial holder confirms the device has multiple scratches, burrs and gouges in it.A functional evaluation was conducted and confirms the femoral trial holder actuator is not turning freely causing the stated failure.A medical investigation was conducted and confirms it was reported that no patient harm or injury was sustained as a result of this device related incident.The procedure was completed using the same device without delay.Therefore, no further medical assessment is warranted based on the information provided.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 a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.

• Brand Name: JRNY II UNI FEMORALTRIAL HOLDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722110
• Report Number: 1020279-2021-03416
• Device Sequence Number: 3765249
• Product Code: LXH
• UDI-Device Identifier: 00885556692264
• UDI-Public: 00885556692264
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74016424
• Device Catalogue Number: 74016424
• Device Lot Number: 19HSC0011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention