MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	8886630771
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device.The visual inspection of the returned product noted that a tactile and microscopic inspection of the sutures was performed with no abnormalities.The foil was inspected with light assisted microscopy with no abnormalities.The visual inspection of the sample noted one suture and one needle.One needle was received with a broken needle tip.Upon microscopic inspection of the needle, instrument marks were observed at the break site of the needle body.As no sealed samples were returned, functional testing was precluded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during cabg procedure sutures were breaking and one of the needles broke in half.There was no injury to the patient.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7079647
• Report Number: 9612501-2017-06680
• Device Sequence Number: 13677987
• Product Code: GAM
• UDI-Device Identifier: 10884523003284
• UDI-Public: 10884523003284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 08/31/2021
• Device Model Number: 8886630771
• Device Catalogue Number: 8886630771
• Device Lot Number: D6H2751X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1