MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, NATURAL

Model Number	635H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in 2210968-2020-06799, 2210968-2020-06800, 2210968-2020-06802.A manufacturing record evaluation was performed for the finished device batch number ppmems, and no non-conformance's were identified.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.Could you please confirm device's availability?.
Event or Problem Description
It was reported that a patient underwent an oral procedure on (b)(6) 2020 and suture was used.During the procedure, the suture broke when surgeon used it.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/23/2020.Additional h3 investigation summary: seven unopened samples of product code 635, lot # phm955 were received for evaluation.During the visual inspection of seven unopened samples, no defects were found on the package.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 strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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: GUT CHR UD 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10520943
• Report Number: 2210968-2020-06801
• Device Sequence Number: 14286998
• Product Code: GAL
• UDI-Device Identifier: 10705031007161
• UDI-Public: 10705031007161
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 11/30/2024
• Device Model Number: 635H
• Device Catalogue Number: 635H
• Device Lot Number: PPMEMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1