MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 20CM 130D; NAIL, FIXATION, BONE

Catalog Number	71675211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 6 months after being implanted, the nail broke in proximal part.Revision for total hip replacement was required.
Additional Manufacturer Narrative
Please review attached for investigation results.

• Brand Name: INTERTAN 11.5MM X 20CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6878273
• Report Number: 1020279-2017-00763
• Device Sequence Number: 1405958
• Product Code: JDS
• UDI-Device Identifier: 03596010565167
• UDI-Public: 03596010565167
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2017

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: 71675211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017; 09/11/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 09/28/2017; 12/27/2017
• 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
• Patient Age: 26 YR