MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 5-0 D/A G-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	792G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Event or Problem Description
It was reported that during an unknown procedure on an unknown date suture was used.The needle kept breaking off of the suture before the first pass through tissue.It is unknown how the procedure was completed and there were no patient consequences reported.

• Brand Name: GUT CHR UD 18IN 5-0 D/A G-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8454646
• Report Number: 2210968-2019-79712
• Device Sequence Number: 354652
• Product Code: GAL
• UDI-Device Identifier: 10705031011755
• UDI-Public: 10705031011755
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 792G
• Device Lot Number: MHK493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/26/2019
• Patient Sequence Number: 1