MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH TIB ALIGN M/L TRANS TUBE; PRSTHSIS,KNEE,PATLLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71442165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery when tightening the tibial alignment assembly, the plastic rod broke, subsequently, the surgeon had to switched to an intra-modulary technique to complete the procedure.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned orthomatch tibia alignment trans tube indicated that a portion of the tube fractured off.A portion of the broken piece was returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated no clinically relevant patient documentation was provided; however, it was reported that the procedure was completed with an im technique using a device from a second set with only a 5 minute delay.No patient harm/injury was reported, therefore, no further medical assessment is warranted at this time.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 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: PRSTHSIS,KNEE,PATLLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7608446
• Report Number: 1020279-2018-01143
• Device Sequence Number: 11108309
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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): 09/01/2018

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: 71442165
• Device Lot Number: 16CSY0018
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/27/2018
• Supplement Date Received by Manufacturer: 05/27/2018
• Initial Report FDA Received Date: 06/16/2018
• Supplement Report FDA Received Date: 09/03/2018
• 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: Other; Required Intervention