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

Model Number	88862775-41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2016
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.Post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.However, analysis suggests that the product was not used in a surgical procedure.The visual inspection and functional evaluation of the product had acceptable results.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During cardiac surgery, the suture thread broke.Used another device to complete the case, no medical or surgical intervention was needed.No patient injury.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: 6813987
• Report Number: 9612501-2017-06004
• Device Sequence Number: 102963
• Product Code: GAT
• UDI-Device Identifier: 10884521105102
• UDI-Public: 10884521105102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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: 08/31/2020
• Device Model Number: 88862775-41
• Device Catalogue Number: 88862775-41
• Device Lot Number: D5H1742X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• 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