MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 38CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675513
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery where femoral nail was replaced with a hip prosthesis due to nail breakage at proximal level (subtrocantheric fracture).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: INTERTAN 10S 10MM X 38CM 125D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6750031
• Report Number: 1020279-2017-00569
• Device Sequence Number: 1615296
• Product Code: JDS
• UDI-Device Identifier: 00885556344347
• UDI-Public: 00885556344347
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 06/18/2026
• Device Model Number: 71675513
• Device Catalogue Number: 71675513
• Device Lot Number: 16FM15380
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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