MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	SN-764
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when utilizing the mattress suturing technique while closing an open radical resection of back melanoma, the needle broke when passing through a thick tissue.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of three devices.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foils were inspected with light assisted microscopy with no abnormalities.The visual inspection of the opened sample noted one suture and three needles.The open needle had a broken swage end, and under microscopic inspection found instrument marks.A bend moment test was performed on the undamaged needles, and the results exceeded the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Grasping the needle at the swaged end can cause the needle to bend or break.The needle should always be held in the middle where the diameter is greatest.Should new information become available, the file will be r e-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when utilizing the mattress suturing technique while closing an open radical resection of back melanoma, the needle broke when passing through a thick tissue.New suture strand was used to complete the case.There was no patient injury.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7242234
• Report Number: 9612501-2018-00170
• Device Sequence Number: 834575
• Product Code: GAR
• UDI-Device Identifier: 20884521080185
• UDI-Public: 20884521080185
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 06/30/2022
• Device Model Number: SN-764
• Device Catalogue Number: SN-764
• Device Lot Number: D7F0847X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR