MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A CC175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 component code: g07002 - 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.Al 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.Please confirm whether the needle piece or the suture broke during the procedure.Can you identify the lot number and product code used? were there any patient consequences? it was mentioned, "this is not a new occurrence; we have had multiple incidents at the start of this year, and there is currently one open investigation regarding a 3-0 prolene." have these events been previously reported to ethicon? if yes, please provide the pc number.*please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) 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.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, while preforming haemostasis on ur first lsited patient the vascular registrar used two 7-0 prolene 9.3 cc needle.These two needles snapped and pulled apart upon tying.The only instrument used was a racheted needle holder on the needle itself.There was nothing used on the thread, the first suture seemed to just fall apart in their hands.It was noticed that the sutures werefrom the same batch.This is not a new occurance, we have had multiple at the start of this year and currently one open investigation on a 3-0 prolene.What were the immediate actions taken? : the sutures were removed from the field with the needles attached and the corresponding packets.Labled with date, surgeon and case number.Ufortunately after two breaking the surgeon chose different measures of haemostasis.As detailed above the sutures were from the same lot/batch, the remaining sutures with the matching were removed from ourshelf.Aer completed and an email will be sent to clinical engineer team and the company rep.The sutures will be made available for the clinical engineering team to collect for inspection.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/20/2025.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.H6 component code: g07002 no device problem found.Corrected information: d4 udi.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One empty winding former and one needle-suture piece and two suture pieces that pertain to product code w8704 were received for analysis.The product code is double armed.During the visual inspection of the needle, the swage and attachment area were noted to be as expected.The suture pieces received were inspected, and no breakage suture was observed.Even though the extremes were noted to be cut and split.Furthermore, damaged (crushed and wavy) and body fluids were also observed along the strand.As per the condition of the returned sample, the functional test could not be performed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed.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 will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 24IN 7-0 D/A CC175-8 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: 23126279
• Report Number: 2210968-2025-10886
• Device Sequence Number: 7442437
• Product Code: GAW
• UDI-Device Identifier: 10705031128248
• UDI-Public: (01)10705031128248(17)291231(10)1065BC
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/23/2025

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: W8704
• Device Lot Number: 1065BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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