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

Model Number	8886623331
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a proximal pancreaticoduodenectomy, while the device was used for anastomosis of the bile duct and anastomosis of jejunum, the device, needle was detached from the thread, to resolve the issue the surgeon repeated the anastomoses and used another device to complete the case.The surgical time was extended more than 30 minutes and there was a tissue damage due to the device problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received three devices.A tactile and microscopic inspection of the sutures was performed with no abnorm alities.A needle attachment test was performed on the sealed samples, and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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: 7847613
• Report Number: 9612501-2018-01582
• Device Sequence Number: 11259300
• Product Code: GAM
• UDI-Device Identifier: 20884523002413
• UDI-Public: 20884523002413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 8886623331
• Device Catalogue Number: 8886623331
• Device Lot Number: D7K1553X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention