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 Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mg5137 batch number, and no non-conformances were identified.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: please confirm the total qty involved / specific number of devices (total qty actually involved with reported issue) that failed during this procedure for "suture was fraying when being used"? 2 each packages from same lot failed.Was procedure completed successfully? procedure was completed successfully.Note: events reported via mw # 2210968-2020-01591.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and suture was used.The suture was fraying when being used.The procedure was completed successfully there were no patient consequences reported.

• 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: 9874001
• Report Number: 2210968-2020-02316
• Device Sequence Number: 16939764
• Product Code: GAL
• UDI-Device Identifier: 10705031037458
• UDI-Public: 10705031037458
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 05/31/2023
• Device Model Number: G123H
• Device Catalogue Number: G123H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1