MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 3-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z497G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.It reported that the device is breaking too easy.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.What was the initial procedure? what is the procedure & event date? could you please confirm if the issue occurred before used it in patient or during use? please clarify.Please confirm what was breaking, in event description it is unclear "the device is breaking"? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-01075, mw # 2210968-2022-01076.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/11/2022.H6 component code: g07002 no device problem found.H3 investigational narrative: one opened box with twelve packets of product code z497 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the sample no external damages were observed on the packet.In order to evaluate the conditions of the returned 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 damages, breakage on body, tip or swage area were observed during evaluation.Functional test was performed, to needles by resistance and met the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of 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.

• Brand Name: PDSII CLR 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13538436
• Report Number: 2210968-2022-01077
• Device Sequence Number: 12049000
• Product Code: NEW
• UDI-Device Identifier: 10705031061231
• UDI-Public: 10705031061231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 08/31/2026
• Device Model Number: Z497G
• Device Catalogue Number: Z497G
• Device Lot Number: RKMACH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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