MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8557H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.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 provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Were any concomitant procedures performed? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle fragment? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? lot number? will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2025 and suture was used.During the procedure, the surgeon found that the tip of the needle had broken off in the heart.The tip of the needle was not recovered.Unknown if an x-ray was performed.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: e1.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Were any concomitant procedures performed? not to my knowledge on what tissue was the suture used? vascular what was the tissue condition (normal, thin, calcified, fragile, diseased)? information not available for the original intended closure, how were all layers closed? not applicable this was for vascular grafting.How was the suture placed (interrupted or continuous)? continuous what instruments were used to grasp the needle? vascular needle holder.Where was the needle grasped during use? information not available.Were x-rays performed to localize the needle fragment? information not available were the needle piece(s) retrieved during the same procedure? no.Does the piece/device remain retained in the patient's tissue? unsure.If the piece(s) were retained, where are they located/in what structure? information not available.If retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? please describe any medical/surgical intervention required for this suture event including dates and results.Not available.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? not to my knowledge other relevant patient history/concomitant medications? information not available what is the physician¿s opinion as to the etiology of or contributing factors to this event? information not available.What is the patient's current status? unknown surgeon¿s name? (b)(6).Lot number? not available will product be returned? if so, please provide the return date and tracking information.No.

• Brand Name: PRLNE BLU 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24208316
• Report Number: 2210968-2026-01047
• Device Sequence Number: 12139420
• Product Code: GAW
• UDI-Device Identifier: 10705031017061
• UDI-Public: 10705031017061
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8557H
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown