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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had performance pull off suture needle.It was received for analysis unopened samples.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum 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, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Additional information was requested and the following was obtained: when event of needle pop-off occurred/when was it noticed: already detached needle-suture in package ? or pre-op - during dispensing before used on patient ? or intra-op- during use on patient? i am unable to provide any additional information regarding this complaint.
Event or Problem Description
It was reported that a patient underwent a surgical procedure on an unknown date and suture was used.During the procedure, the needle popped off the suture.There were no adverse patient consequences reported.No additional information is available.

• 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: 8586484
• Report Number: 2210968-2019-81116
• Device Sequence Number: 1537072
• Product Code: GAN
• UDI-Device Identifier: 10705031059139
• UDI-Public: 10705031059139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 04/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1