MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 4MM; KNEE,PATEL/FEMOROTIBIAL,SEMICONSTRAINED,UNCEMENTED,POROUS,COATED,POLYMER/METAL

Catalog Number	71434304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument broke in two during surgery.There was no harm to the patient and all pieces were found and located.There was a backup device available.No delay reported.
Additional Manufacturer Narrative
The associated legion offset coupler trial was returned and evaluated.A visual examination of the returned product indicated that it has fractured in half.Both pieces were returned.The connection screw is assembled through the offset coupler male part into the offset coupler female part with a thread locking agent.An additional set screw is assembled on top of the connection screw in the offset coupler male part to fasten it during surgery.If an excessive amount of torque is applied to the set screw, torque may be transferred to the connection screw leading to a fracture.The cause for the break in the offset coupler trial connection screw may be attributed to excessive torque applied to the set screw.This instrument was manufactured in 2010 and it shows signs of significant wear/usage.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; 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.

• Brand Name: LGN OFFSET COUPLER TRIAL 4MM
• Common Device Name: KNEE,PATEL/FEMOROTIBIAL,SEMICONSTRAINED,UNCEMENTED,POROUS,COATED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8242090
• Report Number: 1020279-2019-00135
• Device Sequence Number: 2153956
• Product Code: MBH
• UDI-Device Identifier: 03596010547972
• UDI-Public: 03596010547972
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2019

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: 71434304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1