MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH TIB ALIGN M/L TRANS TUBE; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY

Model Number	71442165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the ortomatch tibial bolt was broken, no procedure, delay, injury or back up reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A small section of the plastic tube fractured off at the end of the device.The section was not returned.The device was manufactured in 2016 and exhibits signs of extensive wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ORTHOMATCH TIB ALIGN M/L TRANS TUBE
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8059527
• Report Number: 1020279-2018-02422
• Device Sequence Number: 1684293
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (Y/N): N
• 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): 03/13/2019

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 Model Number: 71442165
• Device Catalogue Number: 71442165
• Device Lot Number: 16CSY0018
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1