MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX42CM 125D LT; NAIL, FIXATION, BONE

Model Number	71676561
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to broken intertan with sub troch screw.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: INTERTAN 1.5 11.5MMX42CM 125D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6820756
• Report Number: 1020279-2017-00660
• Device Sequence Number: 13467839
• Product Code: JDS
• UDI-Device Identifier: 00885556038048
• UDI-Public: (01)00885556038048(17)250805(10)15HM02970
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: Health Professional
• Device Expiration Date: 08/02/2025
• Device Model Number: 71676561
• Device Catalogue Number: OR71676561
• Device Lot Number: 15HM02970
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2017
• Supplement Date Received by Manufacturer: 08/05/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/13/2017
• 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: 66 YR