MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 13 X 40 130 D TAN RT ROSE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71648440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be performed due to broken trigen tan nail.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.[(b)(4)].

• Brand Name: 13 X 40 130 D TAN RT ROSE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6853967
• Report Number: 1020279-2017-00725
• Device Sequence Number: 19213096
• Product Code: HSB
• UDI-Device Identifier: 03596010501387
• UDI-Public: 03596010501387
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/01/2018

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: 04/09/2023
• Device Catalogue Number: 71648440
• Device Lot Number: 13DM08836
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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; Other; Required Intervention