MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 5 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	MB66G
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
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 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.H3 analysis summary: according to the information received, it was reported that was reported that the primary package of the suture was found damaged prior to use.The product was returned to ethicon for evaluation.The returned product determined that it was received one unopened overwrap that pertained to the product code mb66g.During the visual assessment of the overwrap packet, it was noted that the needle was out of the primary packet.In addition, the overwrap packaging was examined, and the sterile barrier was not compromised.In addition, a photo was provided with the same condition as the received sample.Based on the information currently available, a needle out of the folder/tray was identified in the sample during the visual inspection of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance a review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an unknown orthopedic surgery on (b)(6) 2024 and suture was used.It was noted that the primary package was damaged prior to use.Changed to another one to complete the surgery.No patient consequence was reported.No further information was provided.

• Brand Name: EB EXC GRN 4X30IN 5 S/A V-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19086141
• Report Number: 2210968-2024-04001
• Device Sequence Number: 17917864
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: 10705031046290
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: MB66G
• Device Lot Number: TGBHZT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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