MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z496G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.H6 component code: g07002 device not returned.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.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.Could you please clarify if the patient suffer from any sign or consequence? please provide more information what was used to complete the procedure? device return status.Please document the shipment tracking number:.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the thread broke in half on the first pass through the patient's skin, making it impossible to use.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).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, h4 a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information was requested and the following was obtained: 1.Could you please clarify if the patient suffer from any sign or consequence? please provide more information a: he had no consent for the patient.2.What was used to complete the procedure? a: another envelope of the same suture was opened and it did not present any problems.3.Device return status.Please document the shipment tracking number: a: no return process was opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/29/2024.H6 component code: c22 - photo analysis.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.The returned product determined that it was received one suture piece that pertained to the product code z496g.During visual inspection of the returned sample, it was observed that the suture piece belongs to pds clear.The suture was examined, and the end of the suture was noted to be cut, probably caused by a surgical instrument.The other section of the suture was not returned for analysis.In addition two photos were provided for evaluation and both showed a foil and a suture piece inside a bag.The product code z496g contains an absorbable suture.As the sample was received open, and the time of exposure to the environment cannot be determined.Due to the condition of the returned sample, the functional test could not be performed.As part of the 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 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 Manufacturer Narrative
(b)(4).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 h6 investigation findings: b15 and c22 - photo review photo review: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an aluminum package with product code z496g opened, a section of suture inside a plastic bag.A clear analysis could not be performed as the photo becomes distorted when magnified.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: PDSII CLR 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; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18441342
• Report Number: 2210968-2024-00049
• Device Sequence Number: 17844596
• Product Code: NEW
• UDI-Device Identifier: 10705031061217
• UDI-Public: 10705031061217
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2024

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 Catalogue Number: Z496G
• Device Lot Number: THMBQT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 02/28/2024; 04/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/29/2024; 03/07/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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