MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. ORTHOMATCH TIB ALIGN M/L TRANS TUBE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71442165
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the operation of anthem knee joint implantation, a distal part of the tube of the tibial guide broke.There were no broken pieces of the instrument.
Additional Manufacturer Narrative
The tibial alignment tube assembly was returned and evaluated.A visual inspection found that the device has broken on the distal end allowing the carriage assembly, lock knob and lock screw nut to fall out of the device.All of the components were returned but some of the plastic from the align transition tube was not returned.Plastics are prone to brittle fractures and a crack may have initiated during use or due to the heating and cooling associated with autoclaving.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the complaint history for the batch did not find additional complaints.Reviewing the manufacturing records also 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 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.

• Brand Name: ORTHOMATCH TIB ALIGN M/L TRANS TUBE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7912362
• Report Number: 1020279-2018-01847
• Device Sequence Number: 1936539
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142807
• 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): 11/18/2018

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 Catalogue Number: 71442165
• Device Lot Number: 16CSY0020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/18/2018
• 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