MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UK RESECT AP BLOCK LM/RL SZ 7; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74016407

Device Problems Flaked (1246); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, while performing the ukr procedure with a journey ii ukr loan set, the femoral lugs were prepared with the femoral peg drill through one (1) jrny ii uk resect ap block lm/rl sz 7.It would not pass through smoothly, and it was noticed when it finally went through and was retracted, there was a sliver of metal debris.More than one piece was noticed and all were removed from the patient and the block.The procedure was performed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Results of investigation: the devices were not returned for evaluation.However, the photographs were reviewed, and revealed some metal debris and scratches on the surface of the drill.A review of the production order of the block did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Drill batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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 block.A review of complaint history for the previous 12 months did not reveal similar events for the drill.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect 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 the devices or 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 UK RESECT AP BLOCK LM/RL SZ 7
• Type of Device: 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: 17940604
• MDR Text Key: 325745887
• Report Number: 1020279-2023-01948
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556689981
• UDI-Public: 00885556689981
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74016407
• Device Lot Number: 21FM21269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PART NUMBER: 74016421 / LOT NUMBER: UNKNOWN.