MAUDE Adverse Event Report: ETHICON INC. ABSORBABLE SURGICAL SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number NW9248

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one empty foil, one folder, a needle, and some suture pieces that pertain to product code nw9248.Upon visual assessment of the needle, the swage and attachment area was noted to be as expected.The barrel hole was examined under 20x magnification and the remnant suture was observed.In addition, the suture pieces have begun with a degradation process caused by exposure to the environment.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Per the sample condition, the functional test cannot be performed.As part of the 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.Additional investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that it was received six unopened samples that pertain to the product code nw9248.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the 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.Related medwatch reports: 2210968-2023-01253.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.The suture materiel gave away from the swage end of needle while opening the foil during the surgery.Upon evaluation, the suture was degradate and there were wrinkles and holes in the foil packaging.No additional information was provided.

• Brand Name: ABSORBABLE SURGICAL SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-AURANGABAD INDIA; 312379@b-15/1; m.i.d.c., 1 walu; aurangabad
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16407868
• MDR Text Key: 310236102
• Report Number: 2210968-2023-01252
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NW9248
• Device Lot Number: T0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1