MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8720ZH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).H6: type of investigation: b21 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The following information was requested, but unavailable: did the reported issue contribute to any patient adverse consequences? how many devices demonstrated the alleged deficiency? if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions: additional information was requested, and the following was obtained via: our failure analysis lab received three extra product with reference to this complaint, it was received: product code: (3) 8720z.Product lot/batch: 10aslq.Tracking#: (b)(4).Received at cg labs on 6/4/2026.1.Could you please clarify if extra devices belongs to this complaint? 2.If not, could you please clarify if the extra received products belongs to a different complaint? if so, can you please provide the complaint number.3.If the devices was not reported before, please provide more details of device malfunction.4.If the products doesn't belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.The sutures i sent in for analysis should be for complaint#: (b)(4).When i reported the complaint, i remember the representative asking me how many ea were left in the box ¿ there were 9 left so i those 9 in.They did not keep the sutures that had the issue.I am not sure how many sutures had the issue.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2026 and suture was used.During the procedure, it was reported by the customer to the sales rep that during an unknown procedure, that the needles kept popping off on the suture.No patient consequences reported.Devices are available to return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25511289
• Report Number: 2210968-2026-06367
• Device Sequence Number: 10496964
• Product Code: GAW
• UDI-Device Identifier: 10705031465008
• UDI-Public: (01)10705031465008(17)300831(10)8720ZH
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/15/2026

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: 8720ZH
• Device Lot Number: 10ASLQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2025
• 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