MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, NATURAL

Model Number	G123H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a section procedure on (b)(6) 2022 and suture was used.While suturing the uterus, the needle popped off the suture, into the patient.The same needle was found and removed.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: was the needle it retrieved during the same surgical procedure? yes.Was there any additional tissue damage as a result of searching for the needle piece? none reported.Was additional dissection required in other organs/tissues other than the target tissue? none reported.What is the most current patient health status and condition? patient current status unknown, no -severe harm reported.Did the needle break? the needle did not break, it came off the suture strand.Lot number? unknown.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 # (b)(4).Date sent to the fda: 4/26/2022.H3 investigational summary: one opened foil packet, an empty opened foil and a needle of product code g123h were returned to ethicon inc for analysis.In order to evaluate the conditions of the returned sample, the swage area and hole of the needle were noted with marks that appear to be from the surgical instruments, and the hole was observed without a suture remnant.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.The suture was not received for evaluation to determine the assignable cause.The manufacturing records couldn't be reviewed as the batch number is unknown.The condition of the sample received indicates improper handling of the device.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is 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: GUT CHR UD 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13901724
• Report Number: 2210968-2022-02174
• Device Sequence Number: 17160147
• Product Code: GAL
• UDI-Device Identifier: 10705031037458
• UDI-Public: 10705031037458
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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 Model Number: G123H
• Device Catalogue Number: G123H
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown