MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN RK HK OFFSET COUPLER TRIAL STD 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71431909
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inside screw of the legion rk hk offset coupler trial std 4mm seemed stripped: it would not tighten or loosen when screwdriver was inserted.A back-up device from smith and nephew was available.Issue was noticed in lab; therefore, no patient was involved.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN RK HK OFFSET COUPLER TRIAL STD 4MM
• 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: 10379818
• Report Number: 1020279-2020-03778
• Device Sequence Number: 17031987
• Product Code: HRY
• UDI-Device Identifier: 00885556537329
• UDI-Public: 00885556537329
• 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): 07/30/2021

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 Catalogue Number: 71431909
• Device Lot Number: 19ASC0001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1