MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 24IN 7-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	W8725G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.During the procedure, the suture rupture during suturing at (leader zone) swage point.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.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.Attempts have been made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information.Did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? were x-rays taken to locate the needle? was there any patient consequence or injury? what is the patient¿s current health status and condition? was any other tissue damaged as a result of searching the needle? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-02176, 2210968-2023-02177 and 2210968-2023-02180.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/27/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received, a needle suture piece that pertains to product code w8725.The product code is double-armed.During visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The suture was examined, and the end of the suture was noted to be cut probably caused by a surgical instrument.In addition, the other section of the suture was not returned for analysis.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.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: 2210968-2023-02175, 2210968-2023-02176, 2210968-2023-02177, 2210968-2023-02180.

• Brand Name: PROLENE BLU 24IN 7-0 D/A C-1
• 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; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16632902
• Report Number: 2210968-2023-02175
• Device Sequence Number: 7243708
• Product Code: GAW
• UDI-Device Identifier: 10705031242241
• UDI-Public: 10705031242241
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Model Number: W8725G
• Device Catalogue Number: W8725G
• Device Lot Number: SGBDQE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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