MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8534H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle broke off during the procedure from the suture material with no needle left in the patient.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: was the needle piece(s) retrieved during the same procedure? yes.Were x-rays taken to locate the needle piece(s)? no.What measures were taken to retrieve the broken piece? no measures to locate broken pieces.Was there any additional tissue damage as a result of searching for the needle piece? nothing stated.Investigation summary: an opened box with fourteen packets of product code 8534h was returned for evaluation.Visual inspection and functional testing were conducted on the returned devices.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The needles were intact and no anomalies, or breakage needle were observed during analysis.Functional test was performed, to needle by resistance and met the requirements.The event described could not be confirmed as the device performed without any defect noted.In addition, the functional test was performed using a instron and the tensile force were above the minimum requirements.As part of quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances 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, 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.

• Brand Name: PROLENE SUTURE 8"(20CM) 3-0 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14985910
• Report Number: 2210968-2022-05352
• Device Sequence Number: 13836634
• Product Code: GAW
• UDI-Device Identifier: 10705031016774
• UDI-Public: 10705031016774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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: 8534H
• Device Catalogue Number: 8534H
• Device Lot Number: QKBATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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