MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCURIS TIBIAL INSERT HANDLE; PROSTHSIS, KNE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, METAL/POLYMR

Model Number	71236012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the item broke inside of the patient.Surgery was not delayed and it is not known if there was an s and n backup device available.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The paddle end on the trial insert handle fractured off, rendering the device inoperable.Both pieces were returned.A small section fractured off the tibial trial and the piece that fractured off was not returned.The device also has some gouges in the surface around the fracture site.The devices were manufactured in 2013 and 2018 and show signs of extensive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments 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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ACCURIS TIBIAL INSERT HANDLE
• Common Device Name: PROSTHSIS, KNE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9717445
• Report Number: 1020279-2020-00572
• Device Sequence Number: 329461
• Product Code: HSX
• UDI-Device Identifier: 03596010589897
• UDI-Public: 03596010589897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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 Model Number: 71236012
• Device Catalogue Number: 71236012
• Device Lot Number: 13AM10025
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1