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

Model Number	74016404
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use when the instrument was inside the patient, 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.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A dimensional evaluation of the returned device did not confirmed the stated failure mode.The device was met the specifications.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 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of 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.
Additional Manufacturer Narrative
D4: lot number and expiration date added.H4: manufacture date added.(b)(4).

• Brand Name: JRNY II UNI RESECT AP BLOCK LM/RL 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
• MDR Report Key: 10172116
• Report Number: 1020279-2020-02576
• Device Sequence Number: 1848194
• Product Code: HSX
• UDI-Device Identifier: 00885556689950
• UDI-Public: 00885556689950
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74016404
• Device Catalogue Number: 74016404
• Device Lot Number: 18MM12663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020; 09/08/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/09/2021; 09/20/2021
• 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: Other