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

Model Number	Y416H
Medical Device Problem Code	Break (1069)
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).A manufacturing record evaluation was performed for the finished device lot ml5094, and no non-conformance's were identified.Investigation summary: it was reported performance breakage needle.An opened box with unopened samples of product code y416, lot # ml5094 were received for evaluation.The complaint sample was not received for evaluation.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance breakage needle were found.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.What was used to complete the procedure? were x-rays taken to locate the needle piece(s)? was the needle piece(s) retrieved during the same procedure? does a piece of the needle remain in the patient¿s tissue? what tissue structure is it located? size of the needle piece retained are any plans in place to remove the needle piece in future? if retained, what is the surgeon's opinion of consequences to the patient? was there any additional tissue damage as a result of searching for the needle piece? what is current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent a hysterectomy on an unknown date and suture was used.During the procedure, the suture tip broke.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: MCRYL UD 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9642217
• Report Number: 2210968-2020-00791
• Device Sequence Number: 2040807
• Product Code: GAN
• UDI-Device Identifier: 10705031059122
• UDI-Public: 10705031059122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 09/30/2023
• Device Model Number: Y416H
• Device Catalogue Number: Y416H
• Device Lot Number: ML5094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1