MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 2MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434302
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka, a lgn offset coupler trial 2mm did not function correctly.Instrument outside the patient.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
H6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode but could confirm that the device has scratches on it.A functional evaluation was performed on the device and confirmed the stated failure mode.The internal adjustment screw inside of the coupler will no longer tighten rendering the device inoperable.The device shows signs of extensive use a complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.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.We consider this investigation closed.

• Brand Name: LGN OFFSET COUPLER TRIAL 2MM
• 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: 11798469
• Report Number: 1020279-2021-03922
• Device Sequence Number: 19603341
• Product Code: HRY
• UDI-Device Identifier: 03596010547965
• UDI-Public: 03596010547965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 71434302
• Device Catalogue Number: 71434302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1