MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEWSON SUTURE RETRIEVER; RETENTION DEVICE, SUTURE

Catalog Number	71111579
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a surgery to repair a fractured patella, the suture loop was weak and broke.There was no delay in surgery and no pieces left in the patient.

• Brand Name: HEWSON SUTURE RETRIEVER
• Common Device Name: RETENTION DEVICE, SUTURE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7097449
• Report Number: 1020279-2017-01199
• Device Sequence Number: 1182738
• Product Code: KGS
• UDI-Device Identifier: 03596010510495
• UDI-Public: 03596010510495
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2026
• Device Catalogue Number: 71111579
• Device Lot Number: 16DSM0167
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1