MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP494G
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.During the procedure, g the needle, the needle was broken at the tip.No pieces fell into the patient.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: did the surgery was completed successfully? =>no further information is available.If yes what was used to complete the procedure? no further information will be provided.Attempts have been 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ¿g/m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/30/2021.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.H3 investigational summary: visual analysis of the returned sample determined that on broken needle at the swage part product code pdp494 was received.Marks on the swage area and body needle due to use of the surgical instrument were observed.Upon visual analysis of the returned sample 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.The barrel hole was examined under 20x magnification, and a needle part separated from the needle wall.As per returned conditions of the sample no functional test could be perform.Further analysis of the needle was performed to assess the broken area.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Based on the information currently available, the needle breakage was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Trade name : irgacare®, active ingredient(s) : triclosan, dosage form : suture/solid/parenteral, strength : 2360 g/m.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/25/2021.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.A manufacturing record evaluation was performed for the finished device lot number remaxb and no non-conformances related to the reported complaint condition were identified.Additional h6 component code: g07002 - device evaluation pending.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.¿ trade name - irgacare®, ¿ active ingredient(s) ¿ triclosan, ¿ dosage form ¿ suture/solid/parenteral, ¿ strength ¿ = 2360 g/m.

• Brand Name: PDS PLUS CLR 18IN 4-0 S/A P-3 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12490129
• Report Number: 2210968-2021-08614
• Device Sequence Number: 19919818
• Product Code: NEW
• UDI-Device Identifier: 10705031048416
• UDI-Public: 10705031048416
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2021

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: 04/30/2023
• Device Model Number: PDP494G
• Device Catalogue Number: PDP494G
• Device Lot Number: REMAXB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 12/07/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/25/2021; 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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