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

Model Number	8886612411
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the anastomosis of the pancreatic duct in a proximal pancreaticoduodenectomy (whipple) procedure, the tip of needle broke off and fell into the pancreatic duct.The pancreatic duct was additionally excised to find the broken needle tip and the piece was retrieved successfully.The pancreatic duct was again anastomosed using a new product.The surgical time was extended by more than 30 minutes.There was tissue damage and tissue loss.The incision was extended by less than 3 cm.Patient is under observation.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned samples noted one foil pouch with a retainer, one partial suture and two needles.One of the needles was broken at the swaged end.The broken swaged end of the needle was detached from the suture; the suture was not returned.It was observed, under magnification, that instrument marks were present on the broken swaged end of the needle.The other needle was observed to not be broken and attached to a partial suture.The retainers were inspected with no abnormalities.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The observed instrumentation damages suggested that the needles were grasped improperly at the swaged end of the needle during application.Firmly grasping the needle at the swaged end can deform the crimp, can cause the needle to disengage from the suture, and can cause the needle to break at the swaged end.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter and significantly stronger than at the swaged end.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: 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: 6791347
• Report Number: 9612501-2017-05951
• Device Sequence Number: 1541125
• Product Code: GAM
• UDI-Device Identifier: 20884523001768
• UDI-Public: 20884523001768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990951
• 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): 02/01/2018

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: 10/31/2021
• Device Model Number: 8886612411
• Device Catalogue Number: 8886612411
• Device Lot Number: D6K0880X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1