MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 4 8MM; PROSTHESISKNEEFEMOROTIBIALNONCONSTRAINEDCEMENTEDMETALPOLYMER

Model Number	OR00584202408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, device broke when the insert trial was placed for trialing.No delay.No confirmation of backup has been received.No impact or injury to patient reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured in half and both pieces were returned.The device has numerous nicks and gouges in the surface, particularly around the fracture site.The device was manufactured in 2015 and exhibits signs of extensive wear / usage.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

• Brand Name: ARTICULAR SURFACE SIZE 4 8MM
• Common Device Name: PROSTHESISKNEEFEMOROTIBIALNONCONSTRAINEDCEMENTEDMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9398445
• Report Number: 1020279-2019-04239
• Device Sequence Number: 2258817
• Product Code: HSX
• UDI-Device Identifier: 00885556620151
• UDI-Public: 00885556620151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• 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): 12/23/2019

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: OR00584202408
• Device Catalogue Number: 00584202408
• Device Lot Number: 63254941
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1