MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 36CM 130D LT; NAIL, FIXATION, BONE

Catalog Number	71675289
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was 4 months post op.And was having pain.Dr said the patient was working pretty hard and getting around alot prior to the nail breaking.The broken nail was removed and a new one was implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Per the photos attached to the complaint, the intertan nail fractured into two pieces.Without the actual product returned, we are unable to reach an conclusion to why the nail fractured.A clinical evaluation was conducted and insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.

• Brand Name: INTERTAN 11.5MM X 36CM 130D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7688838
• Report Number: 1020279-2018-01302
• Device Sequence Number: 16836826
• Product Code: JDS
• UDI-Device Identifier: 03596010560988
• UDI-Public: 03596010560988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• 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): 07/14/2018

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: 04/01/2024
• Device Catalogue Number: 71675289
• Device Lot Number: 14DM04267
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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