MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOT RING 180 MM LONG; PIN, FIXATION, THREADED

Catalog Number	71070145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tab at anterior end of foot plate broke.The foot plate broke 7-8 weeks after application.The patient was weight bearing in frame.The patient is a male, above average weight.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the provided pictures confirmed the stated failure.The device fractured in half.A review of complaint history did not reveal additional complaints for the listed device.The medical investigation concluded that without the requested clinical information a thorough medical investigation cannot be rendered.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Should any additional clinical information be provided this compliant will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: FOOT RING 180 MM LONG
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8624140
• Report Number: 1020279-2019-01963
• Device Sequence Number: 2308275
• Product Code: JDW
• UDI-Device Identifier: 03596010429575
• UDI-Public: 03596010429575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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 Catalogue Number: 71070145
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1