MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8743
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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.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 via: - when were the sutures broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify (sutures broke during the handling and during the use) - please provide the source or name of person providing answers to follow-up questions: (please refer the attached email) when did the two needles break (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? correction needed : the suture broke not the needle - 1012cz was not recognized.Please provide the correct lot number of 8725h.Lot # (sdbase) - provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(please refer the attached email) rn- cardiac team she was in on the procedure.Correct event description "it was reported to the sales rep that, the suture broke.There were no patient adverse event.Product is not for return.
Event or Problem Description
It was reported that a patient underwent a knee procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported to the sales rep that, the suture broke.There were no patient adverse event.Product is not for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 2X24IN 8-0 D/A BV175-6 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22922516
• Report Number: 2210968-2025-09982
• Device Sequence Number: 9079424
• Product Code: GAW
• UDI-Device Identifier: 10705031046061
• UDI-Public: (01)10705031046061(17)46568(10)1021XR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: M8743
• Device Lot Number: 1021XR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2024
• 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