MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	812H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a gyn cervical cone biopsy on (b)(6) 2025 and suture was used.During the procedure, the needle broke.The case was extended from one hour to five hours as they searched for the needle tip.The needle tip was located and they were unable to retrieve it.The patient was brought back on wednesday to perform a vaginal hysterectomy to retrieve the foreign body.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.H6 component code: g07002 device not returned.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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? what was the size of the needle used? what was the size of the broken needle fragment? was more than half the needle retained in the patient? why was the vaginal hysterectomy performed? was the vaginal hysterectomy performed just to remove the broken needle piece? were all the needle pieces retrieved during the vaginal hysterectomy? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? please describe any medical/surgical intervention required for this suture event including dates and results.Was the patient treatment or post-operative care altered in any way due to the prolonged surgery time of the cervical cone biopsy? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? 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? will product be returned? if so, please provide the return date and tracking information.
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: h6.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: GUT CHR UD 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• 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: 21220069
• Report Number: 2210968-2025-00879
• Device Sequence Number: 3518013
• Product Code: GAL
• UDI-Device Identifier: 10705031012820
• UDI-Public: (01)10705031012820(17)270630(10)SHMQLZ
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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): 02/11/2025

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: 812H
• Device Lot Number: SHMQLZ
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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: Required Intervention
• Patient Sex: Unknown