MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8581H
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 3/5/2026.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6; h3 investigational summary: the product received for analysis was 8581h.Visual inspection and metallurgical analysis were performed on the returned product.A failed suture needle, labeled as (b)(4), was submitted for fractographic evaluation.The component was identified as product code 8581h.It was requested that hsa assess the fracture mode of the failure.A fracture was observed at the tip of the needle.Two needles were received, only one of the needles contained a fracture.One side of the needle was received; the mating fracture surface was not provided for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.It was reported by a sales rep that, during an unknown surgery, when the product was used on carbonized tissue, the needle did not go through well.The issue may be due to the condition of the body site or possibly the product, so the hospital is requesting an investigation.The clinical department and surgical site are currently unknown.It was not a control release needle.Another product was used to complete the case.During visual inspection of the returned sample, significant marks could be observed on the body needles.The tip of the needles was examined and one was broken at the tip area.While the other needle no issues related to breakage needle were noted during the evaluation.The sample will be shipped to hsa for further analysis due to the needle breakage.Further details are not provided from the hp.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 was requested, and the following was obtained via: please provide the lot number.Unk please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sales rep about the device returning.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).(b)(6).The manufacturing records could not be reviewed as the batch/lot number is unknown.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that two needle suture pieces were received for analysis.The product code 8581h is double armed.During visual inspection of the returned sample, significant marks could be observed on the body needles.The tip of the needles was examined and one was broken at the tip area.While the other needle no issues related to breakage needle were noted during the evaluation.The sample will be shipped to hsa for further analysis due to the needle breakage.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Per the condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• Brand Name: PRLNE BLU 36IN 4-0 D/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24335466
• Report Number: 2210968-2026-01648
• Device Sequence Number: 9754880
• Product Code: GAW
• UDI-Device Identifier: 10705031017368
• UDI-Public: 10705031017368
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/13/2026

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: 8581H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown