MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY EM PROX FIX BRIDGE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440198
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the main spike of a genesis ii tibial alignment spiked fixation rod was missing.As this was noticed in a non-surgical environment (before surgery), there was not any patient involved.
Event or Problem Description
It was reported that the main spike of a journey em proximal fixation bridge was missing.As this was noticed in a non-surgical environment (before surgery), there was not any patient involved.
Additional Manufacturer Narrative
Section b5 was updated with new information received.Internal complaint reference number: (b)(4).Sections d1, d2, d3, d4 & g4 updated with the new information.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.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.

• Brand Name: JOURNEY EM PROX FIX BRIDGE
• 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: 12408138
• Report Number: 1020279-2021-06668
• Device Sequence Number: 3349929
• Product Code: HRY
• UDI-Device Identifier: 03596010214416
• UDI-Public: 03596010214416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71440198
• Device Catalogue Number: 74018351
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 10/07/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/20/2021; 10/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1