MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8977H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information: h6 component code: g07002 - device not returned additional information provided: this file represents the 2nd pull off during the patient procedure.According to feedback of the sales rep on 26-aug-2024 via phone, event date should be april 26, 2024 , quantity of product involved should be 3.If further details are received at a later date a supplemental medwatch will be sent.A review of the batch manufacturing records was conducted, and no related non-conformance's were identified.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 a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.The problem of pulling off suture needle happened when suturing the mucosal.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.The needle did not fell into the patient.Additional information has been requested.

• Brand Name: PROLENE SUTURE 36"(90CM) 2-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 20227408
• Report Number: 2210968-2024-09774
• Device Sequence Number: 3469566
• Product Code: GAW
• UDI-Device Identifier: 10705031022256
• UDI-Public: (01)10705031022256(11)220909(17)270831(10)SKBBPH
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• 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
• Report Date (Section B): 09/16/2024

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: 8977H
• Device Lot Number: SKBBPH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown