MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 5-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Model Number	1626G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent attempts are being made to receive additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? when was the suture broke (in the package, during removal from package, during handling or during use on the patient)? please specify was there any adverse consequence associated with the patient? device return status: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate events were submitted via 2210968-2021-07515.
Event or Problem Description
It was reported that the patient underwent a dental procedure in 2021 and the suture was used.During the surgery, the suture strand broke.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/16/2021.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.H6 component code: g07002 - no device problem found.H3 evaluation: two packets of product were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the tensile strength result were above the minimum requirements.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Note: events reported in 2210968-2021-07515 and 2210968-2021-07516.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/15/2021.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.A manufacturing record evaluation was performed for the finished device lot number rcmppk and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: just spoke with the doctor, surgical procedure was an apicoectomy.The suture would break, was not caught or under any tension.This happened multiple times, unfortunately our sutures of this size were the same lot # so we had to keep using from this same box.This has not been an issue with this product before.Note: events reported in 2210968-2021-07515 and 2210968-2021-07516.

• Brand Name: GUT PL UD 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12343885
• Report Number: 2210968-2021-07515
• Device Sequence Number: 3578862
• Product Code: GAL
• UDI-Device Identifier: 10705031001411
• UDI-Public: 10705031001411
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

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: 02/28/2026
• Device Model Number: 1626G
• Device Catalogue Number: 1626G
• Device Lot Number: RCMPPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/20/2021; 09/15/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/15/2021; 09/16/2021
• Patient Sequence Number: 1