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)
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 procedure the nurse set the needle in the needle holder and left it there, but when trying to use it, the tip of the needle had broken.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.Additional information was requested, and the following was obtained: what was the name of the procedure? no further information is available.What was the procedure date? no further information is available.Please confirm the correct lot number? the possible lot number is rjmhlx.Device return status: the device has been received at (b)(6) and will be shipped.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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: 3/2/2022.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 narrative: a failed suture needle was submitted fractographic evaluation.The component was identified as product code pdp513g.It was requested that assess the fracture mode of the failure.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.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 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 tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Additional complaint information monitoring for potential safety signals is 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
Product complaint # (b)(4).Date sent to the fda: 3/9/2022.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 was requested, the following was obtained: were needle fragments removed from the body during the initial procedure? the issue was found before use.How was it confirmed that there were not needle fragments left inside the body? please see above.How was the procedure completed? no further information is available.No further information will be provided.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: 6/9/2022.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 h6 component code: g07002 no device problem found h3 investigational summary: one paper lid and a needle-suture piece of product code pdp513g were returned to ethicon for analysis.Visual inspection was conducted on the returned sample.Upon visual analysis of the returned sample revealed that the swage and attachment were noted to be as expected, the needle was examined, and the tip of the needle is not present since was miss-formed.Based on the information currently available, the missing needle tip 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.Additional h3 investigational summary: five packets, a paper lid, a needle-suture piece, and a suture piece of product code pdp513g were returned to ethicon for analysis.In order to evaluate the conditions of the returned samples, the swage and attachment area was noted to be as expected.The needles were intact and no damage or breakage on the body, tip, or swage area was observed during the evaluation.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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional complaint information monitoring for potential safety signals is 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
Product complaint # (b)(4).Date sent to the fda: 8/5/2022.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: upon visual analysis of the returned sample of product code pdp513g, a fracture was observed at the tip of the needle.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.No conclusion could be reached as to what caused the damage observed on the needle tip.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: in order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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.

• 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 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: 13161015
• Report Number: 2210968-2022-00058
• Device Sequence Number: 5479057
• Product Code: NEW
• UDI-Device Identifier: 10705031048485
• UDI-Public: 10705031048485
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/05/2022

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: 07/31/2023
• Device Model Number: PDP513G
• Device Catalogue Number: PDP513G
• Device Lot Number: RJMHLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/04/2022; 03/08/2022; 05/19/2022; 07/20/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/02/2022; 03/09/2022; 06/09/2022; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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