MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 2MM; PROSTH,KNEE,PATEL/FEMOROTIB,SEMICONSTRAIN,UNCEMENT,POROUS,COATED,POLY/METAL/POLY

Catalog Number	71434302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device broke during an unspecified procedure.There was a backup device available and the procedure was not delayed.It is unknown if there was an impact to the patient due to this issue.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned offset coupler trial indicated that it fractured in two.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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN OFFSET COUPLER TRIAL 2MM
• Common Device Name: PROSTH,KNEE,PATEL/FEMOROTIB,SEMICONSTRAIN,UNCEMENT,POROUS,COATED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8212964
• Report Number: 1020279-2019-00024
• Device Sequence Number: 14139626
• Product Code: MBH
• UDI-Device Identifier: 03596010547965
• UDI-Public: 03596010547965
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/12/2019

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: 71434302
• Device Lot Number: 10BM08594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1