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	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a total knee procedure on (b)(6) 2019 and suture was used.During the procedure, the needle popped off of the suture.It is unknown how the procedure was completed and there were no patient adverse consequences reported.There is no additional information.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluation summary: one empty opened box and nine representative samples of product code y417, lot mjk835 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of nine 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 condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in report 2210968-2019-88868.Analysis results have been included in follow up reports for each.

• 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
• MDR Report Key: 9213476
• Report Number: 2210968-2019-88869
• Device Sequence Number: 2589265
• Product Code: GAN
• UDI-Device Identifier: 10705031059139
• UDI-Public: 10705031059139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Catalogue Number: Y417H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1