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	01/29/2019
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 surgery on (b)(6) 2019 and suture was used.The suture pulled away from needle.Procedure successfully completed.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mkk752 number, and no non-conformances were identified.Device evaluated by mfr: an empty opened foil, a paper lid and a winding former of product code y417, lot mkk752 were returned for analysis.No suture or needle were returned for evaluation to determine the assignable cause of the performance pull off suture needle; therefore, the reported failure could not be evaluated.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident of ¿suture pulled away from needle.¿.

• 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: 8369928
• Report Number: 2210968-2019-79070
• Device Sequence Number: 1057757
• 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): 01/30/2019

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: 01/30/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1