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

Catalog Number	G123H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that a patient underwent a tonsillectomy procedure and suture was used.The suture was used on the soft palate and the needle broke off and fell into the patient.The pieces of the needle were found and retrieved by cutting away additional tissue and retrieved with a needle holder.The procedure was completed with a like device.The current condition of the patient is reported as good condition.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: how was the broken needle retrieved from the patient? -it was retrieved by cutting away additional tissue and retrieved with a needle holder.Was the procedure completed successfully? yes.Was there any adverse consequence associated with the patient? - pt received additional anesthetics.Name of the procedure? tonsillectomy and adenoidectomy.Tissue on which used? soft palate.Lot number unknown.What is the patient¿s current health status and condition? health status is good/ condition is good.Device return status? - in route to facility.

• Brand Name: GUT CHR UD 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9580431
• Report Number: 2210968-2020-00300
• Device Sequence Number: 374739
• Product Code: GAL
• UDI-Device Identifier: 10705031037458
• UDI-Public: 10705031037458
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: No Information
• Device Catalogue Number: G123H
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention