MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RING 180MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71070115X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision will be done due to proximal ring being broken.Surgeon found the tibial non-union.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Please see attached file for our results of investigation.(b)(4).

• Brand Name: FULL RING 180MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6777790
• Report Number: 1020279-2017-00609
• Device Sequence Number: 18887297
• Product Code: KTT
• UDI-Device Identifier: 00885556119556
• UDI-Public: (01)00885556119556(17)430327(10)15JSM0390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: No Information
• Device Model Number: 71070115X
• Device Catalogue Number: 71070115X
• Device Lot Number: 15JSM0390
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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; Required Intervention