MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 3-0 S/A KS; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP523H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformance's were identified.Summary: it was received for analysis an empty opened foil, a detached needle and a dispensed suture of product.During the visual inspection of the needle the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.Per the sample condition, the assignable cause of the performance pull off suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.
Event or Problem Description
It was reported that the patient underwent a c-section procedure on (b)(6) 2020 and the suture was used.During procedure, the needle popped off of the device.A similar device was used to complete the case with no patient consequences.

• Brand Name: MCRYL+ UD 27IN 3-0 S/A KS
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9809301
• Report Number: 2210968-2020-01865
• Device Sequence Number: 2704139
• Product Code: GAM
• UDI-Device Identifier: 10705031046627
• UDI-Public: 10705031046627
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 08/31/2020
• Device Model Number: MCP523H
• Device Catalogue Number: MCP523H
• Device Lot Number: MKK993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1