MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 36IN 2 S/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B402
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).(b)(4).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.
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2020, and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/5/2021.Additional b5 event description: while closing the uterus with barbed suture, the suture was separated from its needle.In order to finish to close the uterus, a different suture was used and the tissue was closed successfully.Additional h6 component code: g07002 - conforming device.A manufacturing record evaluation was performed for the finished device batch qcbbrk, sxpp1b402 and no non-conformances were identified.Additional h3 investigation summary: it was reported that the suture was separated from its needle.It was received for analysis an opened box with an unopened sample of product code sxpp1b402, lot qcbbrk.During the visual inspection of an unopened sample, no defects were found on the package.The sample was opened, and swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed and the pull force were 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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.This report is being submitted pursuant to the provisions of 21 cfr, part 803 and part 4.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.

• Brand Name: STFX SPI PDS+ UNI VIO 36IN 2 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11052280
• Report Number: 2210968-2020-10170
• Device Sequence Number: 1257249
• Product Code: NEW
• UDI-Device Identifier: 10705031236059
• UDI-Public: 10705031236059
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 02/28/2022
• Device Model Number: SXPP1B402
• Device Catalogue Number: SXPP1B402
• Device Lot Number: QCBBRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1