MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 6H 82MM; PLATE, FIXATION, BONE

Catalog Number	71829006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed to replace a fractured plate.
Additional Manufacturer Narrative
Add'l info.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: 3.5MM LCK TUBULAR PL 6H 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6570413
• Report Number: 1020279-2017-00341
• Device Sequence Number: 74818
• Product Code: HRS
• UDI-Device Identifier: 03596010525567
• UDI-Public: 03596010525567
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033669
• 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,Followup
• Report Date (Section B): 09/28/2017

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 Catalogue Number: 71829006
• Device Lot Number: 15FT56144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided; 04/20/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 05/26/2017; 09/28/2017
• 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