MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1667G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/10/2024.Correction to (b)(4).G3 should be 5/13/2024 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/17/2024.The manufacturing record evaluation was performed and identified a non conformance, which was raised to address the event reported.The necessary actions have been taken to address the issue.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.
Event or Problem Description
It was reported that patients underwent mastopexy breast surgery and abdominoplasties on (b)(6) 2024, and suture was used.During procedures, the needles were breaking off.They are breaking after the surgeon passes through the skin and goes to grab the needle to pull it through.As he is pulling it through, the needle snaps off with any tension on it.The surgeon hasn¿t changed how he is using the suture or tying the knots.The facility just received a new box and it is already gone as they all broke.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/10/2024 h6 component code: g07002 no device returned a review of the batch manufacturing records was conducted, and no related non-conformances were identified.The single complaint was reported with multiple events.Additional information was requested, the following was obtained: the event occurred over several days on 3 different cases on (b)(6) all intra op not sure exactly how many sutures were used but probably around 12- 16 total from 2 different boxes we noticed this pattern of needles breaking over these three cases.Not sure how many were used on each patient this is the first time reported to ethicon all 3 cases were mastopexies unsure of the quantity involved per procedure.We didn¿t keep track.We used several from each box and they were both the same lot #s.We just noticed this unusual pattern over the course of these 3 cases.We use this exact sure all the time and this has never happened.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.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.Related reports: 2210968-2024-05346, 2210968-2024-05347, 2210968-2024-05997, 2210968-2024-05998, 2210968-2024-05999, 2210968-2024-06000, 2210968-2024-06001, 2210968-2024-06004, 2210968-2024-06005, 2210968-2024-06006, 2210968-2024-06007, 2210968-2024-06008.

• Brand Name: ETHLN BLK 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19506127
• Report Number: 2210968-2024-06005
• Device Sequence Number: 15309482
• Product Code: GAR
• UDI-Device Identifier: 10705031001817
• UDI-Public: 10705031001817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 1667G
• Device Lot Number: TPBCUB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 06/17/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/10/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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