MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 96IN 1 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP880G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 qjmape / pdp880g38, and no non-conformances related to the reported complaint condition were identified.Attempts are being 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.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿= 2360 g/m.
Event or Problem Description
It was reported that the patient underwent liver resection procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke about an eighth of an inch from the swedge while suturing the facia.The broken piece of the needle was retrieved.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/26/2021.Additional information h6: 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.H3 evaluation: a failed suture needle was submitted for fractographic evaluation.The component was identified as product code pdp880g.It was requested to assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The cleaning process was repeated to remove adherent particles from the fracture surface.Some debris remained on the surface; however, additional cleaning was not performed in order to preserve the fine fractographic features.The specimen was then air-dried and stored until analysis.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿= 2360 g/m.

• Brand Name: PDS PLUS VIO 96IN 1 S/A TP-1 LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11372046
• Report Number: 2210968-2021-01746
• Device Sequence Number: 714643
• Product Code: NEW
• UDI-Device Identifier: 10705031048669
• UDI-Public: 10705031048669
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 07/31/2022
• Device Model Number: PDP880G
• Device Catalogue Number: PDP880G
• Device Lot Number: QJMAPE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/26/2021
• Patient Sequence Number: 1