MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 2-0 D/A SH-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X559H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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 a mitral valvuloplasty procedure on an unknown date; and a suture was used.During the procedure, the suture broke while sewing.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/13/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/19/2020.H3 evaluation: it was received for analysis an opened sample of product code x559h, lot paz879.During the visual inspection of the opened sample, the suture was observed broken and the section.A functional test was performed and the tensile strength force was above the minimum requirement.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 received, it could not be determined what may have caused the reported incident suture broke.The reported complaint was observed.

• Brand Name: EB EXC GRN 36IN 2-0 D/A SH-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9995347
• Report Number: 2210968-2020-03466
• Device Sequence Number: 11813000
• Product Code: GAT
• UDI-Device Identifier: 10705031057593
• UDI-Public: 10705031057593
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• 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): 04/22/2020

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: 12/31/2023
• Device Model Number: X559H
• Device Catalogue Number: X559H
• Device Lot Number: PAZ879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 05/19/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/13/2020; 05/19/2020
• Patient Sequence Number: 1