MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	636H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 the patient underwent dental surgery on an unknown date and suture was used.During the procedure, the surgeon placed needle into gum tissue and the suture strand broke off from the needle at the swage.The procedure was completed with a like device.There were no adverse patient consequences reported.

• Brand Name: GUT CHR UD 27IN 3-0 S/A FS-2
• 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: 8364081
• Report Number: 2210968-2019-79028
• Device Sequence Number: 19409990
• Product Code: GAL
• UDI-Device Identifier: 10705031007185
• UDI-Public: 10705031007185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 636H
• Device Lot Number: MGM305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• Patient Sequence Number: 1