MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 7-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8800H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a an unknown procedure on an unknown date and suture was used.The customer came across some sutures that were unusable in theatre today.The scrub team stated that when rolling the needle out to arm the needle holder, the thread was tangled and broke, along with the needle.This happened with three sutures, all from the same box and batch number.Customer has removed any existing stock from their stores.There was no patient involvement.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/13/2025.H6 component code: g07002 - no device problem found.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, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: can you identify the lot number of the product involved? it was reported that ".The thread was tangled and broke, along with the needle." please clarify, did the suture and needle break? or was just the suture? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with twenty unopened samples was received for analysis.The product code 8800h is double armed.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were found on the packages.The packets were open, and the swage and attachment area were noted to be as expected.Additionally, the tip and body of the needles were examined and no needle breakage were found.The sutures were dispensed without problems and examined along of the strand and no issue related to breakage suture or anomalies were observed during evaluation.The samples were tested by resistance test to needle and met the requirements.Besides that, the functional test was performed using an instron equipment and the tensile force was above the minimum requirements.As part of 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.

• Brand Name: PRLNE BLU 18IN 7-0 D/A C-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22793186
• Report Number: 2210968-2025-09286
• Device Sequence Number: 8643136
• Product Code: GAW
• UDI-Device Identifier: 10705031020610
• UDI-Public: (01)10705031020610(17)280731(10)TJBBXZ
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 8800H
• Device Lot Number: TJBBXZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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