MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	635H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 clarify the event "needle broke off of the suture": did the needle break in the middle? no broke at junction of proximal third with middle third.Did the thread break in the middle? no.Did the needle separate from the thread? no.
Event or Problem Description
It was reported that a patient underwent a dental extraction procedure in (b)(6) 2018 and suture was used.During the procedure, the needle broke off of the suture while it was being pulled through tissue.The procedure was completed with an additional suture of the same product code from a different lot.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: GUT CHR UD 27IN 4-0 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: 7450757
• Report Number: 2210968-2018-72269
• Device Sequence Number: 11160864
• Product Code: GAL
• UDI-Device Identifier: 10705031007161
• UDI-Public: 10705031007161
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 10/31/2022
• Device Catalogue Number: 635H
• Device Lot Number: LMZ493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1