MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8533H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained via: was the needle removed from the patient during the same procedure? yes.What tissue/location was suturing when pull off occurred? not sure, i could not get a hold of the physician, but the issue happened during a hernia repair.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no.Procedure date? (b)(6) 2021.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.Note: events reported via 2210968-2021-05698 and 2210968-2021-05699.
Event or Problem Description
It was reported that a patient underwent a hernia repair on (b)(6) 2021 and suture was used.During the procedure, the needle got detached from the suture.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 8/19/2021.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, or its employees that the report constitutes an admission that the product, ethicon, 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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: PROLENE SUTURE 8"(20CM) 2-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12032430
• Report Number: 2210968-2021-05697
• Device Sequence Number: 13783453
• Product Code: GAW
• UDI-Device Identifier: 10705031016743
• UDI-Public: 10705031016743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 08/31/2025
• Device Model Number: 8533H
• Device Catalogue Number: 8533H
• Device Lot Number: QKBEQA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1