MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: lot of the product.Ac7966.Surgical procedure performed.Diaphragmatic plication by thoracoscopy.Patient demographics.(b)(6), male, (b)(6) year.Was there any damage / consequence to the patient due to the problem with the suture? no.Was there a surgical delay due to the problem with the suture? yes, 20 min.Does the hcp consider that the delay could have caused death / serious injury / harm / consequence to the patient? if yes, explain the risk assessed by the doctor.If the suture had been left, it could have caused recurrence of the problem and/or complication; that's why it was changed to suture "ceroa" what is the current state of the patient? discharged.Name and full address of the clinic / hospital that reports.(b)(6).Will the product be able to be recovered for analysis? no, the suture was discarded after the rupture.
Event or Problem Description
It was reported that the patient underwent diaphragmatic plication by thoracoscopy procedure on (b)(6) 2019 and suture was used.The doctor was suturing the diaphragmatic wall, when the suture began to disengage and finally broke.A new suture was used to continue the procedure, which was delayed by 20 minutes.There were no patient consequences were reported.The patient has been discharged.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device ac7966 number, and no non-conformances were identified.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8689882
• Report Number: 2210968-2019-82637
• Device Sequence Number: 19313904
• Product Code: GAT
• UDI-Device Identifier: 10705031049338
• UDI-Public: 10705031049338
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: PXX52
• Device Lot Number: AC7966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1
• Patient Age: 1 YR