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

Catalog Number	71933931
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that rail has bent, preventing complete lengthening to occur and causing the patient to fall into a varus deformity.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.The medical investigation concluded that the undated images provided revealed progression of the laterally positioned distal femur along with a varus deformity.Currently, we are unable to rule out initial lateral alignment of the distal femur and the lack of pre-operative adaptations to prevent movement of limb segments as contributing factors to the reported event.The patient impact beyond aesthetics, altered joint wear/gait, possible revision surgery, additional rehabilitative therapy, and radiological exposure cannot be concluded but if there is correction of this deformity, another procedure would be required or a permanent deformity may impact their function.No further medical assessment can be rendered at this time.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: 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: 8091281
• Report Number: 1020279-2018-02540
• Device Sequence Number: 19207902
• Product Code: KTT
• UDI-Device Identifier: 00885556065334
• UDI-Public: 00885556065334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090926
• 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): 09/24/2019

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: Health Professional
• Device Catalogue Number: 71933931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DEVICE/UNKNOWN LOT; UNKNOWN DEVICE/UNKNOWN LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention