MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, NATURAL

Model Number	G121H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number qmmduq, and no non-conformances were identified.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.Could you please clarify if the needle was left in patient's body? were x-rays taken to locate the needle piece(s)? are any plans in place to remove the needle piece in future? if retained, what is the surgeon's opinion of consequences to the patient? what is the current condition of the patient? 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Per user facility medwatch form, mw (b)(4), during a vaginal laceration repair, patient was being stitched.There was a snap heard and the needle disappeared into the vagina.No device will be returned.Three were no patient consequences reported.

• Brand Name: GUT CHR UD 27IN 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12681017
• Report Number: 2210968-2021-10181
• Device Sequence Number: 1181447
• Product Code: GAL
• UDI-Device Identifier: 10705031037434
• UDI-Public: 10705031037434
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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: No Information
• Device Expiration Date: 10/31/2025
• Device Model Number: G121H
• Device Catalogue Number: G121H
• Device Lot Number: QMMDUQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR