MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J493G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, it was reported by the sales rep that during the unknown procedure, the doctor was suturing the patient when the needle broke in patients skin while holding onto the needle driver.The doctor managed to get the needle out but had to cut into the patients skin deeper.They got a new suture of same type.The replacement needle almost broke off as well but the doctor managed to stop to prevent needle from moving into fat tissue deeper.The patient was informed and understood not to move.The report appeared to be a procedure where the patient was awake using local anesthetic.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(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.Attempts have been made to retrieve the device.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.What was the size of the needle used? was more than half the needle retained in the patient? where was the needle retained; in what structure? could you confirm if the needle broke 2 times on the same patient? were prescription steroids administered? were antibiotics prescribed? what medical/surgical intervention was provided? location of inflammation? was any surgical intervention performed specifically re-suturing? events reported via: 2210968-2022-05010.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 9/23/2022 additional information was requested, the following was obtained: did the second needle bend? was there any deficiency noted with the second needle? per staff second needle was also bending however, the dr.Was more vigilant and careful.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 Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 08/02/2022 h6 component code: g07002 - device not returned 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2022-05008 and 2210968-2022-05010.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/1/2022 additional information: h3, h6 h6 component code: c22 - photo analysis additional information was requested, the following was obtained: what was the size of the needle used?- 5-0 was more than half the needle retained in the patient?- the whole needle where was the needle retained; in what structure?- retained in full form right shoulder of patient in fatty tissue could you confirm if the needle broke 2 times on the same patient?- 1st broke entirely, 2nd almost broke in the same patient were prescription steroids administered?- no were antibiotics prescribed?- no what medical/surgical intervention was provided?- had to cut deeper into patient to retrieve needle location of inflammation?- none was any surgical intervention performed specifically re-suturing? ¿ no device return status?- discarded in sharps, did take pictures h3 investigational summary ¿ photo analysis: this is an analysis of three photos submitted to ethicon for review.During the visual analysis the following was observed: the photo shows product code j493g with the needle connection area bent.Marks were observed on the attachment due to the use of the surgical instrument.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A P-3 PRM MP
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14877122
• Report Number: 2210968-2022-05008
• Device Sequence Number: 5690143
• Product Code: GAM
• UDI-Device Identifier: 10705031040496
• UDI-Public: 10705031040496
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2022

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 Expiration Date: 02/28/2026
• Device Model Number: J493G
• Device Catalogue Number: J493G
• Device Lot Number: RCMCMH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 08/19/2022; 09/15/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/02/2022; 09/01/2022; 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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