MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CHROMIC GUT; SUTURE, ABSORBABLE, NATURAL

Model Number	UG-203
Medical Device Problem Codes	Material Frayed (1262); Knotted (1340); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively in ent procedures they mentioned septoplasties, the surgeon finds that the needle keeps breaking off from the thread, the suture is fraying, and it is coming out of the pack with knots in it.Five unopened sutures will be returned for analysis but the rep is unsure if they are all from the same lot number that has the issue.The account has not provided any more information other than that it has happened in numerous cases and do not have one specific patient event.No patient details are listed.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of five devices.The visual inspection and functional evaluation of the samples had ac ceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHROMIC GUT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7073907
• Report Number: 9612501-2017-06678
• Device Sequence Number: 13730444
• Product Code: GAL
• UDI-Device Identifier: 20884521056142
• UDI-Public: 20884521056142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K885018
• 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,Followup
• Report Date (Section B): 03/01/2018

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: 04/30/2020
• Device Model Number: UG-203
• Device Catalogue Number: UG-203
• Device Lot Number: D7D0536ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1