MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK LM/RL SZ 1; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74016403

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 02/04/2020

Event Type  Injury  

Event Description

It was reported that during use when the instruments were inside the patient, the cut blocks produced metal shaving when contacted by the drill in the femur prep process.There was a delay between 0-30 min.The surgery was finished with the same device.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device was various nicks and burrs.A dimensional evaluation confirmed the stated failure mode.The device was found to be out of specification.A health hazard evaluation was also performed and concluded that the risk level was determined to be low.The clinical/medical evaluation concluded that this case reports that while using the journey ii cutting blocks metal shavings were produced when drilling.It is unknown if the metal shavings were removed from the patient.Without the requested clinical information, the reported issue could not be further assessed.The material for the device is 17-4 ph stainless steel and is manufactured and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 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.A potential probable cause statement could be but is not limited to an error in manufacturing.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 LM/RL SZ 1
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10174765
• MDR Text Key: 195760412
• Report Number: 1020279-2020-02609
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74016403
• Device Lot Number: 19GM01454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Distributor Facility Aware Date: 02/04/2020
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention