MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PATELLA REAMER GUIDE; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 74019201

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka surgeryt, a journey patella reamer guide's spring mechanism on handle broke, it is unknown if any pieces fell inside the patient.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H6: the device, used in treatment, was returned and evaluated.A visual inspection of the returned journey patella reamer guide confirmed the spring in the middle of the device is broken.This device also has extensive wear usage.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.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 PATELLA REAMER GUIDE
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12114809
• MDR Text Key: 260477137
• Report Number: 1020279-2021-05674
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010557308
• UDI-Public: 3596010557308
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 07/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 74019201
• Device Lot Number: 10JM20636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1