MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J944H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.(b)(4).Investigation summary: an opened box with twelve packets of product code j944h was returned to ethicon inc for analysis with the packaging closed.Upon initial inspection, of the sample, no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The needles were intact and no damages, breakage on the body, tip, or swage area were observed during evaluation.Functional test was performed, to needle by resistance and met the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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, weight, bmi at the time of index procedure? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? please provide name and full address of where to send the shipper kit for return of product.Please follow up with customer to see if they want a replacement box or credit.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required due to this needle breakage, including dates and results.Did the operating surgeon observe any needle deficiency or anomaly before or during use? what instruments were used to grasp the needle? where was the needle grasped during use? what was the size of the broken 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? how long was the surgery delayed? were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.Was the post-operative care changed due to this event? please specify.This medwatch report is in response to receipt of facility report #(b)(4).
Event or Problem Description
It was reported that a patient underwent a vaginal delivery on (b)(6) 2022 and suture was used.During the procedure, while doing a repair following the delivery, the needle broke.The doctor was suturing when she noticed half of the needle had broken off.The doctor couldn¿t find it in the patient and took her back to our or for better visualization.An xray was done and showed that the missing half was still in the patient.The patient was taken to the main or where the on-call urologist was called to help.The doctors were still unable to locate and retrieve the missing half of the broken needle.This resulted in patient having prolonged hospitalization, intervention and temporary harm.Additional information was requested.

• Brand Name: VCL CT BRD UD 36IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13789744
• Report Number: 2210968-2022-01853
• Device Sequence Number: 14429611
• Product Code: GAM
• UDI-Device Identifier: 10705031043640
• UDI-Public: 10705031043640
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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 Expiration Date: 06/30/2026
• Device Model Number: J944H
• Device Catalogue Number: J944H
• Device Lot Number: RHMDDX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female