MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 8MM; TEMPLATE

Model Number	00584102508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, tibial trial broke while trialing components.No delay.Backup device available.No injury or impact to patient reported.All pieces were recalled and removed from the patient.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.This device was manufactured in 2015.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 5 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8452411
• Report Number: 1020279-2019-01180
• Device Sequence Number: 11098109
• Product Code: HWT
• UDI-Device Identifier: 00885556619568
• UDI-Public: 00885556619568
• Combination Product (Y/N): N
• 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): 03/06/2020

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: 00584102508
• Device Catalogue Number: 00584102508
• Device Lot Number: 63254968
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1