MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK RM/LL SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74016414
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during uka surgery, a journey device had considerable metal abrasion, it occurred during femoral preparation.It is unknown how the procedure was completed or if this causes any delay.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Corrected data: b5, h6 (health effect - impact code).
Event or Problem Description
It was reported that, during uka surgery, a journey device had considerable metal abrasion, it occurred during femoral preparation, all the pieces were accounted and removed with suction.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: d4 (part number, lot number, unique identifier (udi) # and expiration date), g2 (pma/510(k)number), h4 corrected data: b5, d1.
Event or Problem Description
It was reported that, during uka surgery, a jrny ii uni resect ap block rm/ll sz 4 had considerable metal abrasion, it occurred during femoral preparation, all the pieces were accounted and removed with suction.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Results of investigation: the associated devices were returned and evaluated.The visual inspection revealed that the pin holes of the cutting block have metal abrasions, burrs and gouges.The femoral peg drill was returned as well and the visual revealed that the drill is dull.These failure modes are related as both occurred because of extensive use and the devices show significant signs of wear and usage.This inspection was conducted using a magnifying glass.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II UNI RESECT AP BLOCK RM/LL SZ 4
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 19512656
• Report Number: 1020279-2024-01125
• Device Sequence Number: 20705171
• Product Code: HSX
• UDI-Device Identifier: 00885556690055
• UDI-Public: 00885556690055
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2024

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: 74016414
• Device Lot Number: 21GM07025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 07/16/2024; 08/03/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/17/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 74016421 / LN: 21HNX0144
• Patient Sex: Unknown