MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 12IN 4-0 D/A M-1; SUTURE, ABSORBABLE, NATURAL

Model Number	744G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).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 measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? what is the lot number? device return status: 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.
Event or Problem Description
It was reported that a patient underwent a procedure to repair an unknown structure on an unknown date in (b)(6) 2022 and suture was used.During use on the patient, the needle was described as breaking into 2 parts.Both parts were recovered from the patient with no consequence to the patient.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.

• Brand Name: GUT CHR UD 12IN 4-0 D/A M-1
• 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: 13981307
• Report Number: 2210968-2022-02324
• Device Sequence Number: 20303794
• Product Code: GAL
• UDI-Device Identifier: 10705031009684
• UDI-Public: 10705031009684
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: 744G
• Device Catalogue Number: 744G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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