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

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

It was reported that the lgn 6 deg valg col ntral s3-8 was stuck in the locked position after reprocessing.The device was able to be unlocked but no longer locks.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirmed the lgn 6 deg valg col ntral s3-8 appear to be seized in the locked position, which would cause the device not to function as intended.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN 6 DEG VALG COL NTRAL S3-8
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11783728
• MDR Text Key: 249253702
• Report Number: 1020279-2021-03826
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010550170
• UDI-Public: 03596010550170
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 71434404
• Device Catalogue Number: 71434404
• Device Lot Number: 18BM07858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1