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

Model Number 74016417

Device Problems Material Fragmentation (1261); Device Damaged by Another Device (2915)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported, that during a journey ii ukr surgery.The lug drill was difficult to pass through the preparation hole of one (1) jrny ii uni resect, ap block rm/ll sz 7.There was a sight of smoke.When preparation was completed.It was noted, there was metal debris in the hole, which was removed.On removal and inspection of the block, the area of damage was seen, and a further spec of debris was seen.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

Results of investigation: the device was not returned for evaluation.However, the photographs were reviewed, and revealed debris on the hole.The device shows signs of use.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months 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 reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument 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 device 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.

Event Description

It was reported that, during a ukr surgery, the lug drill was difficult to pass through the preparation hole of one (1) jrny ii uni resect ap block rm/ll sz 7, there was a sight of smoke.When preparation was completed it was noted that there was metal debris in the hole, which was removed.On removal and inspection of the block, the area of damage was seen, and a further spec of debris was seen.Furthermore, some metal debris was removed from the patient.The procedure was completed, after a non-significant delay, with the same device.No further complications were reported as a consequence of this problem.

Manufacturer Narrative

Corrected data: b5.

Manufacturer Narrative

Updated results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device reveals the pin holes have burrs and gouges.The device shows signs of extensive wear and use.The visual did not reveal any debris in the pin holes.However, a visual inspection of the images provided by the costumer after the surgery, reveal debris on the hole and external to the patient.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 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.This device is a reusable instrument 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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II UNI RESECT AP BLOCK RM/LL 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: 17199070
• MDR Text Key: 317988591
• Report Number: 1020279-2023-01364
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556690086
• UDI-Public: 00885556690086
• 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,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74016417
• Device Catalogue Number: 74016417
• Device Lot Number: 21KBG0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1