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

Catalog Number	71442165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tibial alignment guide tube broke whilst being tightened.Delay of less than 30min reported.No injury reported.No back up reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ORTHOMATCH TIB ALIGN M/L TRANS TUBE
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8218119
• Report Number: 1020279-2019-00053
• Device Sequence Number: 1656674
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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): 05/22/2019

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: 71442165
• Device Lot Number: 16CSY0019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1