MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PATELLA REAMER GUIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74019201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spring of the journey patella reamer guide is broken.Event occurred during surgery with instruments inside the patient.Procedure was finished with the same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information was received from reporter stating that the device did not break inside the patient.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Event or Problem Description
It was reported that the spring of the journey patella reamer guide broke during surgery, outside the patient.Procedure was finished with the same device.No harm or inconvenience was caused to the patient.
Event or Problem Description
It was reported that the spring of the journey patella reamer guide broke.Event occurred during surgery, with instruments outside the patient.Pieces fell inside the wound and were retrieved (nothing was left in the patient).Procedure was finished with the same device.No harm or inconvenience was caused to the patient.
Additional Manufacturer Narrative
Additional information was received from reporter stating that, even though the device broke outside the patient, some pieces did fell inside the wound.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does meet the threshold for reporting and is a reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reamer guide broke, with pieces falling inside the patient.Per email communication, all pieces were removed from the patient, and the procedure was completed using the same device, without patient injury.Since no patient harm is alleged, no further clinical assessment is warranted.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product 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 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.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: JOURNEY PATELLA REAMER GUIDE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293450
• Report Number: 1020279-2020-03328
• Device Sequence Number: 13655824
• Product Code: HRY
• UDI-Device Identifier: 03596010557308
• UDI-Public: 3596010557308
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2021

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 Catalogue Number: 74019201
• Device Lot Number: 06JM04717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 08/02/2020; 08/31/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 07/22/2020; 08/13/2020; 09/02/2021
• 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: Required Intervention