MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP513G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 lot number qhmctm, and no non-conformances related to the reported complaint condition were identified.The product upon which this medwatch is based has been received, however, at time of submission, evaluation not yet in complete status and therefore not reported in the initial medwatch.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained: what tissue was being approximated or sutured when it broke? skin closure.What was used to complete the procedure? same material.Trade name - irgacare¿.Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: 2360 g/m.Events were submitted via 2210968-2021-02753 and 2210968-2021-02754.
Event or Problem Description
It was reported that the patient underwent an unknown surgery in 2021 and the suture was used.It was reported that the suture breakage occurred during skin closure.There were no patient consequences.Another like suture was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4) date sent to fda: 04/16/2021 this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information: d9, h3, h6 h3 analysis summary: visual analysis of the returned samples determined that a sealed box (36ea) and an opened box with twenty-four unopened samples of product code pdp513g were received for evaluation.Visual inspection of thirteen unopened samples was conducted.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage or suture breakage were noted.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The devices performed without any defect noted.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength = 2360 ¿g/m events were submitted via 2210968-2021-02752, 2210968-2021-02753 and 2210968-2021-02754 (b)(4) date sent to fda: 04/16/2021 this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Corrected information: d3 trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength = 2360 ¿g/m.

• Brand Name: PDS PLUS VIO 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11573019
• Report Number: 2210968-2021-02752
• Device Sequence Number: 3598745
• Product Code: NEW
• UDI-Device Identifier: 10705031048485
• UDI-Public: 10705031048485
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K061037
• 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): 03/01/2021

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: 06/30/2022
• Device Model Number: PDP513G
• Device Catalogue Number: PDP513G
• Device Lot Number: QHMCTM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1