MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863093-61
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was originally reported on a quarterly summary report and is being resubmitted per fda request.
Event or Problem Description
According to the reporter: occurred during an open hernia procedure.The suture broke at the knot.No known patient injury or extension in surgical time.Patient status is alive, no injury.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6813480
• Report Number: 9612501-2017-06001
• Device Sequence Number: 19275667
• Product Code: GAT
• UDI-Device Identifier: 10884521060029
• UDI-Public: 10884521060029
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K961578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2017

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: 12/31/2018
• Device Model Number: 88863093-61
• Device Catalogue Number: 88863093-61
• Device Lot Number: D3M0537X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1