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

Model Number	GMM-573L
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	09/03/2018
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, the needle was detached from the suture while on a running suturing technique during an open vascular surgery procedure.It was reported that there were three defective sutures in total.They used new sutures to complete the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while suturing fascia during an open vascular surgery procedure, the needle was detached from the suture.It was also reported that there were three defective sutures in total.They used new sutures to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.A tactile and microscopic inspection of the sutures was performed with no abnormalities.A needle attachment test was performed on the sealed sample, and the results met the specifications for this product.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 7905409
• Report Number: 9612501-2018-01713
• Device Sequence Number: 1473186
• Product Code: GAM
• UDI-Device Identifier: 10884521104150
• UDI-Public: 10884521104150
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 10/31/2022
• Device Model Number: GMM-573L
• Device Catalogue Number: GMM-573L
• Device Lot Number: D7K2627X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 03/26/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/29/2018; 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1