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

Catalog Number	VCPB977H
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).Date sent to the fda: 8/5/2024.H6 component code: g07002 - pending evaluation of returned device.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.The following information was provided: the kit was registered with jjkk and qa.The registered model number was determined from the kit components.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: product code: 4350xl.Lot : tke3801.1.Please clarify if the additional device belong to this complaint? if so, what is the product code and lot number of the unknown returned product? 2.If not, could you please clarify if the additional 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 and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.A device has been received, however clarification is requested whether the product belongs to this complaint.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: what is the lot number? unk.Please clarify, how many products will be returned for evaluation? two.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.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) (b)(6).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During suturing, the suture was broken 2 times in a row.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/3/2024.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: d4, d9, g1, h3, h4, h6.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Additional information was requested, the following was obtained: product code: 4350xl.Lot : tke3801.1.Please clarify if the additional device belong to this complaint? yes, but there was no issue in 4350x.In japan this interseed and vcpb977h are sold in one box as a kit created in japan, and the kit has been reported as this complaint by the hospital.However, the issue occurred in only the vcpb977h, so we input only vcpb977h in ecm.The interseed was returned with the vcpb977h, but investigation is not required for the interseed.If so, what is the product code and lot number of the unknown returned product? 2.If not, could you please clarify if the additional 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 and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.Tracking number: (b)(4).H3 investigational summary: the product was returned to ethicon for evaluation.Two representative unopened samples were received for analysis.Product code vcpb977h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.

• Brand Name: VCL+ UD 36IN 1 S/A CTXB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19906860
• Report Number: 2210968-2024-08032
• Device Sequence Number: 18343777
• Product Code: GAM
• UDI-Device Identifier: 10705031056770
• UDI-Public: (01)10705031056770(17)280630(10)THMHCB
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: VCPB977H
• Device Lot Number: THMHCB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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