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

Catalog Number	G121H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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- did the needle break into 2 pieces? or did the whole needle detach from suture? did the needle/needle piece fall into patient? if yes, was it removed? and how? any patient consequences / ae outcome as a result of the event report? any medical / surgical intervention done on patient due to the event report? was procedure completed successfully? and how? this medwatch report is in response to receipt of facility report # 1002600000-2018-8006.(b)(6).
Event or Problem Description
It was reported that a patient underwent a vaginal delivery in (b)(6) 2018 and suture was used for a vaginal tear repair.During the procedure, status post vaginal delivery, the suture needle broke during stitch.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Brand Name: GUT CHR UD 27IN 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7923055
• Report Number: 2210968-2018-76180
• Device Sequence Number: 1807553
• Product Code: GAL
• UDI-Device Identifier: 10705031037434
• UDI-Public: 10705031037434
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 04/30/2020
• Device Catalogue Number: G121H
• Device Lot Number: JE6669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/19/2018
• Patient Sequence Number: 1
• Patient Age: 22 YR