MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRIDE INSERT TRIAL SIZE D 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	PFSR101006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that insert trial broke during trialing.It is unknown if pieces needed to be retrieved from the patient or not.But no patient injury was reported.
Additional Manufacturer Narrative
The report was inadvertently submitted under manufacturer number 1020279, but the correct manufacturer number is 3010266064.
Additional Manufacturer Narrative
The device was used in treatment and was returned for evaluation.Dhr review found that the device met manufacturing specification.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.Instructions for trialing the insert trial can be found in the navio surgical technique for use with the stride unicondylar knee system.A visual inspection of the product confirmed the stated failure.The device is broken at the bottom slot.The part shows signs of significant wear/usage.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.

• Brand Name: STRIDE INSERT TRIAL SIZE D 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9984062
• Report Number: 1020279-2020-01341
• Device Sequence Number: 14573449
• Product Code: HSX
• UDI-Device Identifier: 00885556627761
• UDI-Public: 00885556627761
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K123380
• 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,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSR101006
• Device Catalogue Number: PFSR101006
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018; 08/27/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/28/2020; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention