MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8706H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Were x-rays taken to locate the needle piece(s)? was there any additional tissue damage as a result of searching for the needle piece? if not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? was there any change in the patient¿s post-operative care due to the prolonged procedure? what is the surgeon's opinion of consequences to the patient? additional information was requested, and the following was obtained via: was the needle piece(s) retrieved during the same procedure? ans: no.What measures were taken to retrieve the needle piece? ans: x-tray to check on existence, however fail to retrieve any needle.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? ans: yes, up to 4 hours for finding the lost needles.Were there any patient consequences? ans: no.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) ans: answered by physician.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2025 and suture was used.During the procedure, 3 needle and suture break from swage end and needle disappeared and lost during proximal anastomoses.No adverse patient consequences were 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: d9, h3, h6.H3 investigation summary: the product was returned to ethicon for evaluation.One empty winding former that pertains to product code ep8706 was received for analysis.The visual assessment of the product noted that as the suture or needle was not returned, the event described could not be confirmed.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the 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.H3 investigation summary (b03/b15): the product was returned to ethicon for evaluation.Ten (10) unopened samples and one (1) empty label winding former were received for analysis.Product code ep8706 is double armed.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.A photo was provide that show two (2) empty winding formers inside of a plastic bag.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested and the following was provided: were x-rays taken to locate the needle piece(s)? ans: yes ¿ was there any additional tissue damage as a result of searching for the needle piece? ans: no ¿ if not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? ans: no, nothing to be retrieved ¿ was there any change in the patient¿s post-operative care due to the prolonged procedure? ans: no what is the surgeon's opinion of consequences to the patient? ans: follow up screening for the next visit.

• Brand Name: PRLNE BLU 30IN 6-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21987601
• Report Number: 2210968-2025-05075
• Device Sequence Number: 11884025
• Product Code: GAW
• UDI-Device Identifier: 10705031218949
• UDI-Public: (01)10705031218949(17)280430(10)TEBBDX
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/08/2025

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: EP8706H
• Device Lot Number: TEBBDX
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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