MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 38CM 125D LT; NAIL, FIXATION, BONE

Catalog Number	71675247
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed to remove a broken nail.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: INTERTAN 11.5MM X 38CM 125D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6747106
• Report Number: 1020279-2017-00565
• Device Sequence Number: 188012
• Product Code: JDS
• UDI-Device Identifier: 03596010561183
• UDI-Public: 03596010561183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 02/28/2026
• Device Catalogue Number: 71675247
• Device Lot Number: 16CM01771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention