MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 6-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8706
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
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 12/19/2025.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.Additional information was requested; the following was obtained: it was reported that ".Every batch of sutures is breaking off too easy and they've taken it off the shelf".If possible, please confirm the number of procedures/patients affected by this issue.The sutures breaking off were used on one patient and procedure.Due to the sutures continuing to break, the doctor informed the staff to take the two different suture boxes that kept breaking off the shelf and report it to the ethicon rep.How many devices demonstrated the alleged deficiency on each involved patient event? (please refer to the attached mail), the coordinator relayed a couple per box during the procedure.When did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if different, please explain.While the surgeon was attempting to suture during the procedure.(please refer to the attached mail), claims it was during the passing.Lot/batch: 105m6t was initially reported.Were other batches affected by this issue? the other boxes were sent for the first pc (b)(4) that was called in the month october please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The suture box for the below have been sent, customer is awaiting the new return box for the most recent pc.Complaint number: (b)(4).Account name: (b)(6).Center event date: 2025.Event description: it was reported to the dl by the sales rep that the 7-0 proline bv-1 multipass needle that sutures kept breaking during surgery.The 5-0 proline c-1 needle also continued to break.There was no adverse impact on patient/user reported.Devices are available for return.Product name: prlne blu 4x30in 7-0 d/a bv-1, product code: m8703, lot number: 101s6h, qty.: (b)(4).Product name: prlne blu 4x36in 5-0 d/a c-1, product code: m8720, lot number: 1036jj, qty: (b)(4).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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that every batch of sutures is breaking off too easy and they've taken it off the shelf.No adverse impact to the patient/user.Device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 1/21/2026.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.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE BLU 4X30IN 6-0 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23855568
• Report Number: 2210968-2025-14403
• Device Sequence Number: 5129143
• Product Code: GAW
• UDI-Device Identifier: 10705031045811
• UDI-Public: (01)10705031045811(17)291231(10)105M6T
• 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,Followup
• Report Date (Section B): 12/19/2025

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: M8706
• Device Lot Number: 105M6T
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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