MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 11-0 S/A BV50-3; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2881G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and the suture was used.During surgery, the suture broke in two pieces.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: could you please confirm if the patient suffer from any consequence due to the issue (breakage suture)? please provide more details.There were no patients consequences due to breakage of suture.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/15/2022 h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one empty opened overwrap, a folder, and a foam park with a needle and a needle-suture piece that pertain to product code 2881g.In order to evaluate the condition of the needle suture piece, it was noted unusual color on the strand, is not black.Marks were observed on the body needle and the end of the suture was damaged.Due to the condition of the sample, the functional test was not performed.In addition, the needle was examined, and it was noted body fluids in the body needle.The barrel hole of the needle was examined under 20x magnification, and no suture remnant was observed.An analytical characterization experiment, performed on black silk sutures, demonstrated that sutures lost their color within 48 hours if are exposed to a 3% hydrogen peroxide solution.Unopened suture product exposed to hydrogen peroxide vaporization decontamination (such as in an er) would eventually cause these black-colored sutures in current overwrap packaging to lose their black color, but it is not known how many decontamination treatments would be necessary to achieve this.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ETHLN BLK 5IN 11-0 S/A BV50-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15245357
• Report Number: 2210968-2022-06711
• Device Sequence Number: 12224157
• Product Code: GAR
• UDI-Device Identifier: 10705031004191
• UDI-Public: 10705031004191
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 2881G
• Device Catalogue Number: 2881G
• Device Lot Number: MLM086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown