MAUDE Adverse Event Report: ETHICON INC. ETHLN GRN 30IN 4-0 S/A FS-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	G7143H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch rbbetr, and no non-conformances were identified.(b)(4).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: - suture broke during the surgery (removal of naevus).They used another same like suture to complete the procedure.A few hours after the surgery, the patient called to inform the hcp that the suture had come loose.Re-closure on the same day.The following information was requested, but unavailable: on what structure/tissue was nevus located and the suture was used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? did the operating surgeon observe any suture deficiency or anomaly before, or during the suture placement? please specify.Please clarify what does it mean ¿suture got loose ¿? was there any precipitating stress factor for ¿suture got loose¿? please specify.What was used for re-suturing? 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? intra-op event ( suture breakage) submitted via 2210968-2021-10155 post-op event ( suture got loose) submitted via 2210968-2021-08921.
Event or Problem Description
It was reported that a patient underwent a removal of a naevus on (b)(6) 2021 and suture was used.During the procedure, the suture broke.Another like suture was used to complete the procedure.There were no patient consequences reported.

• Brand Name: ETHLN GRN 30IN 4-0 S/A FS-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12678225
• Report Number: 2210968-2021-10155
• Device Sequence Number: 1231466
• Product Code: GAR
• UDI-Device Identifier: 10705031245594
• UDI-Public: 10705031245594
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: G7143H
• Device Catalogue Number: G7143H
• Device Lot Number: RBBETR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1
• Patient Age: 11 YR