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

Model Number	8886612221
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
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, on an open kidney transplant, while suturing during the ureter anastomosis, the needle detached from one end and the needle from the other end of the suture broke.Another suture from the same lot was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four devices.A tactile and microscopic inspection of the sealed sutures was performed with no abnormalities.The visual inspection of the opened sample noted one suture and two needles.A needle was received broken at the swage site and the remaining one was detached.Upon microscopic inspection, instrument marks were observed near the break site and the swage of the needle detached.A needle attachment test was performed the sealed samples, 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 root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end could cause bends or breaks, or damage the connection between the needle and suture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXON CV
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8377766
• Report Number: 9612501-2019-00381
• Device Sequence Number: 2925985
• Product Code: GAM
• UDI-Device Identifier: 10884523002065
• UDI-Public: 10884523002065
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 12/31/2022
• Device Model Number: 8886612221
• Device Catalogue Number: 8886612221
• Device Lot Number: D7M1468X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1