MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX EXT BLOCK LG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	74018609
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
the associated device, intended for use in treatment, was returned and evaluated. a visual inspection of the returned device confirmed the stated failure mode.Device's retaining rings are missing, rendering the device inoperable.The device was manufactured in 2015 and shows signs of extensive use.At this time, we do not have 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.Should 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 or Problem Description
It was reported after the procedure that the spacer block did not function (did not hold the insert).No patient involved in the case.After product evaluation it was determined that the device's retaining rings came out and are missing, rendering the device inoperable.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Device's retaining rings are missing, rendering the device inoperable.The device also shows signs of extensive use.At this time, we do not have 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.Should 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 FLEX EXT BLOCK LG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11729693
• Report Number: 1020279-2021-03513
• Device Sequence Number: 11817258
• Product Code: LXH
• UDI-Device Identifier: 03596010557100
• UDI-Public: 03596010557100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 74018609
• Device Catalogue Number: 74018609
• Device Lot Number: 15FM18512
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1