MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y942G

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The single complaint was reported with multiple events and additional information was requested to clarify the multiple events.There are no additional details regarding the additional events at this time.

Event Description

It was reported that an animal underwent a spay or neuter procedure on (b)(6) 2018 and suture was used.During the procedure, the suture broke and the needle separated from suture upon tying a knot.There were no adverse patient consequences.Another suture was opened to complete the procedure.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Date sent to the fda: 06/12/2018 additional information: investigation summary
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> an opened box with representative samples was returned for analysis.The issue sample was not received for evaluation.During the visual inspection, no defects were found on the packages.The samples were opened and the swage and attachment area of seven needles were as expected.The sutures were dispensed without problems and examined along of strand and no defects or damage were noted.Functional test was performed to samples and the pull force and tensile force met the requirements.Per the condition of the representative samples received, no needle pull off or suture breakage were found.

Manufacturer Narrative

(b)(4).Representative samples were returned for evaluation.The issue sample was not received for evaluation.During the visual inspection of the samples, no defects were found on the packages.The samples were opened and the swage and attachment area of seven needles were as expected.The sutures were dispensed without problems and examined along of strand and no defects or damage were noted.Functional test was performed to samples using a instron and the pull force and tensile force met the requirements.Per the condition of the representative samples received, no performance - pull off suture needle and performance - breakage suture were found and the reported.

• Brand Name: MONOCRYL SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7518670
• MDR Text Key: 108417969
• Report Number: 2210968-2018-72823
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031218642
• UDI-Public: 10705031218642
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: Y942G
• Device Lot Number: LJM969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 06/15/2018
• Supplement Dates FDA Received: 06/12/2018; 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1