MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 0 S/A CT-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8412H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent an unknown procedure on an unknown date and suture was used.Two sutures were disassembled during the procedure.Further information has been requested.
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 information was requested, and the following was obtained: can you identify the batch number of the products that were used? the institution did not report the batches related to the event.-were there consequences for the patient? none reported.Just an additional time for suture change and new tissue coping process.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6.Component code: g07002: device not returned.Related events captured via: 2210968-2024-03166.
Additional Manufacturer Narrative
Product complaint (b)(4) date sent to the fda: 4/2/2024 h6 component code: g07002 no device returned h6 component code: c22 - photo analysis additional information: h6 additional information was requested, the following was obtained: can you identify the lot number of the products that were used? - the institution did not report the lots related to the event.Were there consequences for the patient? ¿ none reported.Just an additional time for suture change and new tissue coping process provide the source or name and title of the external person providing the responses to the follow-up (external person sending the responses to the sales representative) (b)(6) , surgical instrumentist, (b)(6) *please provide the status of the devices as it has not been received for analysis.If the device has been shipped, provide shipping tracking details ¿ the physical suture fragments did not enter, so there is no material to be returned for subsequent analysis.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.H3 photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a winding former with product code 8412h empty.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, the event describe is not confirmed, however 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.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.

• Brand Name: PRLNE BLU 30IN 0 S/A CT-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18932135
• Report Number: 2210968-2024-03167
• Device Sequence Number: 9346306
• Product Code: GAW
• UDI-Device Identifier: 10705031015265
• UDI-Public: 10705031015265
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133356
• 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): 04/03/2024

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: 8412H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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