MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y415H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was 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.Additional information was requested and the following was obtained: lot #: y415h, lh7cwkn.Did any needle fall into patient? no.If yes, was it retrieved? and how? any patient consequences/ae outcome as a result of the event report? no patient consequences known.Was the procedure completed successfully? and how? procedure completed successfully with new sutures.Were both needles that presented with issue being used on same patient / single procedure? yes.
Event or Problem Description
It was reported that a patient underwent a hemicolectomy on (b)(6) 2018 and suture was used.During the procedure, the needle pull-off during tissue passage.Another like device was used to complete the procedure with no adverse patient consequences.Additional information had been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A detached needle, a dispensed suture, one empty labeled winding former and two unopened samples were returned for analysis.During the visual inspection of opened sample, the swage and attachment area were not as expected.Since; the marks of swage area were incomplete instead of double stake.The suture was examined along of strand and the end was damaged.This condition caused the needle pull off suture.Due to condition of the opened sample the assignable cause of the performance - pull off suture needle, is an incorrect swage defect.In the visual inspection of the two unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area of the needles were as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed using a instron and the pull force were above the minimum requirements.Per the conditions of the unopened samples, no attachment defects were found and the tested samples met the finished goods requirements.

• Brand Name: MCRYL UD 27IN 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7518318
• Report Number: 2210968-2018-72819
• Device Sequence Number: 13835081
• Product Code: GAN
• UDI-Device Identifier: 10705031059115
• UDI-Public: 10705031059115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 12/31/2022
• Device Catalogue Number: Y415H
• Device Lot Number: LH7CWKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1