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

Catalog Number	71434306
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr needed to remove the trial, using the slap hammer, dr realized the femoral component came away from the bone, without the stem and offset coupler.On investigation we realized the coupler had broken, part in the femoral trial and part in the trial stem in the medullary canal.He needed to remove some bone from the anterior cortex to gain access to the end of the construct to enable him to grip it with bone nibblers and remove it.On further examination we realized the locking screw in the coupler had fractured.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The clinical/medical team concluded, no clinically supporting documents have been provided for inclusion in this investigation.However, it was reported no patient injury occurred as a result of the instrument breakage intra-operatively.Based on the information provided, no further clinical/medical assessment is warranted at this time.A visual examination of the returned legion offset coupler trial indicated that it has fractured in half.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.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN OFFSET COUPLER TRIAL 6MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7688786
• Report Number: 1020279-2018-01295
• Device Sequence Number: 920202
• Product Code: MBH
• UDI-Device Identifier: 03596010547989
• UDI-Public: 03596010547989
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71434306
• Device Lot Number: 06CM17127
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention