MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 6MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71434306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was returned and evaluated.The visual inspection of the offset coupler trial confirmed the complaint that the set screw has fractured.The cause for the break in the offset coupler trial connection screw may be attributed to excessive torque applied to the set screw.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A quality hold was placed in an attempt to quarantine and re-inspect additional product for this failure mode.This issue has also been communicated to our management process for their consideration of further action.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit has been issued for this device.
Event or Problem Description
It was reported that item broke in stem trial during surgery.Used an identical backup device to complete surgery.Surgery time was not extended more than 30 min.The surgeon does not fault the device.The patient or surgical procedure was not affected in anyway due to the problem.No broken pieces were left inside the patient.

• Brand Name: LGN OFFSET COUPLER TRIAL 6MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis; TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull ; UK ; 0447940038246
• MDR Report Key: 7754695
• Report Number: 1020279-2018-01418
• Device Sequence Number: 7061400
• Product Code: MBH
• UDI-Device Identifier: 03596010547989
• UDI-Public: 03596010547989
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 71434306
• Device Catalogue Number: 71434306
• Device Lot Number: 06CM03760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 07/13/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/05/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown