MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN 6 DEG VALG COL NTRAL S3-8; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434404
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, in a total knee arthroplasty, the legion 6 deg valg col ntral s3-8 did not lock onto reamer.It is unknown when the malfunction was noticed if before, during or after procedure.Smith and nephew back up device available.No delay or injury reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So, the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: LGN 6 DEG VALG COL NTRAL S3-8
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10912592
• Report Number: 1020279-2020-06806
• Device Sequence Number: 3317725
• Product Code: HRY
• UDI-Device Identifier: 03596010550170
• UDI-Public: 03596010550170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2021

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: 71434404
• Device Catalogue Number: 71434404
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1