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

Model Number	SG-5687
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously reported to the fda on a summary report and is now being submitted on a 3500a per fda request.Evaluation summary: post market vigilance (pmv) led an evaluation of post market vigilance (pmv) received two boxes of device.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foils were inspected with light assisted microscopy with no abnormalities.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.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.
Event or Problem Description
According to the reporter, during the procedure, the suture packaging was opened, and grasped with a needle holder.The suture was then removed from packaging and stretched slightly to remove suture memory.This is when the suture snapped at the needle swage."3was" tried from the same box, with the same result.A different box, with the same lot number was tried and the same thing happened.There was no patient harm caused.Current patient status is alive with no injury.The product will be returned for evaluation.

• 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: 7316185
• Report Number: 9612501-2018-00312
• Device Sequence Number: 1605780
• Product Code: GAL
• UDI-Device Identifier: 10884521055766
• UDI-Public: 10884521055766
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 03/04/2018

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: 04/30/2021
• Device Model Number: SG-5687
• Device Catalogue Number: SG-5687
• Device Lot Number: D6D0091NPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 9