MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y417H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.Suture pulled away from needle during use.Procedure was successfully completed no patient consequences,.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received as a labeled winding former, a detached needle and a suture piece of product code, y417, lot mkk752.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected and no suture remnant was observed into the barrel hole.The suture piece was examined, and the impression of the swage area was not found due to the ends were cut appears to by use of a surgical instrument; also body fluids were observed along of suture piece.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.A manufacturing record evaluation was performed for the finished device mkk752 number, and no non-conformances were identified.

• Brand Name: MCRYL UD 27IN 2-0 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: 8387569
• Report Number: 2210968-2019-79234
• Device Sequence Number: 10837266
• Product Code: GAN
• UDI-Device Identifier: 10705031059139
• UDI-Public: 10705031059139
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960653
• 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): 02/06/2019

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: 08/31/2023
• Device Catalogue Number: Y417H
• Device Lot Number: MKK752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1