MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 9IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B433
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 an unknown date and suture was used.During the robotic surgery, the surgeon grabbed the suture with needle holder.After first stitch, the suture was broken.It happened to the next 3-4 sutures in the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (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: please confirm the quantity of sutures that broke during this single procedure.Procedure name and date? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.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.Related to: 2210968-2021-12974, 2210968-2021-12975,2210968-2021-12976.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/23/2022.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.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational narrative: visual analysis of the returned product revealed that three labeled winding former and three suture pieces of product code sxpp1b433 were received to ethicon inc for evaluation.Upon visual inspection of the returned samples, body fluids, crimping and marks were observed on the surface suture possibly from a surgical instrument, in addition, the ends were observed cut.The functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.Additional h3 investigational narrative: two opened samples of product code sxpp1b433 were returned to ethicon inc for analysis.The winding former, paper lid, and foil were not received.In order to evaluate the conditions of the returned samples, the swage and attachment area was noted to be as expected.The suture was examined along the strand to detect any issue on the suture and no defects were observed during evaluation.The product code sxpp1b433 contains absorbable suture, as the sample was received open, the time of exposure to the environment could not be determined.Functional test was performed, and the tensile strength result was above the minimum 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.This report is not intended to deny that you experienced a problem with the device.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.Additional h3 investigational narrative: an opened box with thirteen packets of product code sxpp1b433 was returned to ethicon inc for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the thirteen packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum 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 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.Related to: 2210968-2021-12974, 2210968-2021-12975,2210968-2021-12976, 2210968-2021-12977.

• Brand Name: STFX SPI PDS+ UNI VIO 9IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13088782
• Report Number: 2210968-2021-12977
• Device Sequence Number: 20314795
• Product Code: NEW
• UDI-Device Identifier: 10705031246546
• UDI-Public: 10705031246546
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K150670
• 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
• Report Date (Section B): 02/23/2022

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: 06/30/2022
• Device Model Number: SXPP1B433
• Device Catalogue Number: SXPP1B433
• Device Lot Number: QHBHCZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown