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

Model Number	88863113-81
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively in a knee arthroscopy at the end of the procedure, the suture thread broke.They replaced the suture to complete the case and resolve the issue.The patient was alive with no injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one video of the device being used.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.However, the investigation detected a secondary condition of handling rough that has no relationship to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• 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: 6868268
• Report Number: 9612501-2017-06169
• Device Sequence Number: 11114703
• Product Code: GAT
• UDI-Device Identifier: 10884521060135
• UDI-Public: 10884521060135
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K961578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 06/30/2021
• Device Model Number: 88863113-81
• Device Catalogue Number: 88863113-81
• Device Lot Number: D6F0525X
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1