MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 36CM 125D RT; NAIL, FIXATION, BONE

Catalog Number	71675224
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed less than four months after surgery after the patient felt a snap and was unable to weight-bear.
Additional Manufacturer Narrative
Please see attached for the investigation results.(b)(4).
Event or Problem Description
It was reported during the revision the nail construct was removed.

• Brand Name: INTERTAN 10MM X 36CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6570969
• Report Number: 1020279-2017-00343
• Device Sequence Number: 905656
• Product Code: JDS
• UDI-Device Identifier: 03596010561091
• UDI-Public: 03596010561091
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 09/27/2017

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: 09/29/2024
• Device Catalogue Number: 71675224
• Device Lot Number: 14KM01600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: 85 YR