MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture puled off the needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/29/2020.Additional information was requested and the following was obtained: were there any adverse patient consequences? no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/10/2020.A manufacturing record evaluation was performed for the finished device batch number peu023, and no non-conformances were identified.Additional h3 investigation summary: one needle and one winding former with suture of product code y494, lot peu023 was received for analysis.During the visual inspection of sample, the swage and attachment area of the needle were noted to be as expected.The suture could not be dispensed since has begun with the degradation process and this caused that the needle was separate of the suture.The time of exposure of suture to the environment could not be determined and the functional test cannot be performed.In addition, the foil was not returned to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause is suture degradation.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any adverse patient consequences?.

• Brand Name: MCRYL UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10014586
• Report Number: 2210968-2020-03654
• Device Sequence Number: 13972707
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K964072
• 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,Followup
• Report Date (Section B): 04/27/2020

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: 04/30/2024
• Device Model Number: Y494G
• Device Catalogue Number: Y494G
• Device Lot Number: PEU023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 06/26/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/10/2020; 06/29/2020
• Patient Sequence Number: 1