MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM TRIAL LT SZ 4; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74031224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure a small sliver of metal was seen falling off the trial upon impaction of the trial.No injuries or delays reported.Backup device available.
Additional Manufacturer Narrative
Additional information: h4, d4.The device, used in treatment, was returned for evaluation.The stated failure mode was confirmed through a visual inspection of the returned jrny ii tka fem trial lt sz 4.The femoral trial is damaged.The trial has multiple deep gouges and burrs in the metal.This instrument was manufactured in 2013, and it exhibits signs of excessive use and wear.A clinical evaluation was conducted and based solely on the product evaluation, the root cause of the damage or broken component is likely due to age related wear.The small sliver of metal retained is comprised of 17-4 stainless steel a non-implantable material.Without the requested clinical information or radiographs, the location of the small sliver of metal could not be determined.Therefore, the impact to the patient beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.

• Brand Name: JRNY II TKA FEM TRIAL LT SZ 4
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9309559
• Report Number: 1020279-2019-03935
• Device Sequence Number: 16677261
• Product Code: JWH
• UDI-Device Identifier: 03596010671905
• UDI-Public: 03596010671905
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/09/2020

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 Catalogue Number: 74031224
• Device Lot Number: 13CBG0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1