MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMALL RAIL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71933931
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Rail has snapped, so fracture no longer reduced or healed.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, 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: SMALL RAIL
• 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: 7657631
• Report Number: 1020279-2018-01264
• Device Sequence Number: 184439
• Product Code: KTT
• UDI-Device Identifier: 00885556065334
• UDI-Public: 00885556065334
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: Lay User/Patient
• Device Catalogue Number: 71933931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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