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
Product complaint # (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.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.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"? was procedure completed successfully? do you have the product for return?.
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.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: (b)(6) 2020.Additional information: h6.A manufacturing record evaluation was performed for the finished device mg5137 batch number, and no non-conformities were identified.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, 2210968-2020-02316.

• 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: 9766071
• Report Number: 2210968-2020-01591
• Device Sequence Number: 14116038
• 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,Followup
• Report Date (Section B): 02/03/2020

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
• Device Lot Number: MG5137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1