MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	VS-871
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when passing the needle through the tissue during an open coronary artery bypass procedure, the device needle broke.A new suture was used to complete the procedure with no issues.The patient status is alive with no injury.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6729547
• Report Number: 9612501-2017-05828
• Device Sequence Number: 762267
• Product Code: GAP
• UDI-Device Identifier: 20884521090160
• UDI-Public: 20884521090160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2017

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: 07/31/2021
• Device Model Number: VS-871
• Device Catalogue Number: VS-871
• Device Lot Number: D6G0374X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1