MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP486H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and suture was used.It was reported that needle tip of suture broke off during surgery.Used during orthopedic surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 1/27/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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: how many devices demonstrated the alleged deficiency in total? how many devices demonstrated the alleged deficiency during handling? how many devices demonstrated the alleged deficiency during use? please 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) additional information was requested, the following was obtained: 1) did the reported issue contribute to any patient adverse consequences? ans: unknown.2) when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify ans: during handling and use 3) were x-rays taken to locate the needle piece(s)? ans: unknown.4) what measures were implemented to retrieve the broken piece? ans: unknown.5) was there any additional tissue damage resulting from the search for the needle piece? does a fragment of the needle remain in the patient¿s tissue? ans: unknown.6) if yes, was more than half the needle retained in the patient? is there any plan in place to remove the needle piece in the future? ans: unknown.7) if yes, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? ans: unknown.8) what is the surgeon's opinion of the potential consequences for the patient? ans: unknown.9) please provide the source or title of external person providing answers to follow-up on dd mmm yyyy or provided from knowledge as you were present in the case? : ans: (b)(6) (registered nurse), notified on (b)(6) 2026.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: d9.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/3/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested: product code: (3) vcp486h.Product lot/batch: 107uec.Tracking#: (b)(4) (singapore sg).Received at cg labs on 2/4/2026.1.Could you please clarify if extra device belongs to this complaint? 2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product 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.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one open box with eight unopened samples were received for analysis.Product code vcp486h.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.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 is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: h 3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H3 investigation summary: the product received for analysis was vcp486h.Visual inspection and metallurgical analysis were performed on the returned product.A failed suture needle, labeled as (b)(4) was submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on february 12, 2026.The component was identified as product code vcp486h.It was requested that hsa assess the fracture mode of the failure.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.

• Brand Name: VCL+ VIO 36IN 1 S/A CP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24190255
• Report Number: 2210968-2026-00978
• Device Sequence Number: 12794980
• Product Code: GAM
• UDI-Device Identifier: 10705031053618
• UDI-Public: (01)10705031053618(17)300430(10)1086KJ
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K032420
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2026

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: VCP486H
• Device Lot Number: 1086KJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 03/20/2026; 03/23/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/23/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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