MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z334H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device not returned 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.Additional information was requested and the following was obtained: what was being done when the pull off occurred (e.G.Removal from package, during passage through tissue, during tying, etc.)? during passage and tying.What tissue was being approximated or sutured when the pull off occurred? abdomen/ soft tissue/ endometriöse.Event date? (b)(6) 2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Note: events reported via: mwr-02032021-0000906885, mwr-02032021-0000906886, & mwr-02032021-0000906887.
Event or Problem Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2021 and suture was used.During the procedure, the suture got detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/28/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 and the following was obtained: was surgery delayed due to the reported event? yes.Was procedure successfully completed? yes.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.How long was the surgery delayed? was the procedure delayed because the needle pulled off of the suture intraoperatively? were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient/s treatment altered in anyway due to the prolonged surgery time? if yes, please explain investigation summary : according to the information received, suture is broken from the needle attachment intraoperative.The product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that nineteen unopened samples of product code z334h were received for evaluation.Visual inspection was done on unopened samples and no defects were found on the package.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed and the pull force 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.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/29/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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: h6 health effect- impact code.

• Brand Name: PDSII VIO 27IN 0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11531724
• Report Number: 2210968-2021-02573
• Device Sequence Number: 5513107
• Product Code: NEW
• UDI-Device Identifier: 10705031060562
• UDI-Public: 10705031060562
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N18331
• 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,Followup
• Report Date (Section B): 02/26/2021

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: 04/30/2025
• Device Model Number: Z334H
• Device Catalogue Number: Z334H
• Device Lot Number: QEMCCU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/05/2021; 04/28/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/28/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1