MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A PS-2 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	593H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 verify if two different sutures- 1663g and 593h were used in same procedure.Procedure name did needle piece(s) fall in patient? x-ray takens? results? were needles fully retrieved? were needle piece(s) removed from the patient? during same procedure? any additional tissue damage/ dissection as a result of searching for the needle piece(s)? any other patient consequences? if yes, what medical/surgical treatment was provided?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the needle broke while using it in the tissue.It was unknown if any needle piece fell in to the patient.It was unknown how the procedure was completed.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: ETHLN BLK 18IN 2-0 S/A PS-2 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7407396
• Report Number: 2210968-2018-72021
• Device Sequence Number: 2023790
• Product Code: GAR
• UDI-Device Identifier: 10705031006539
• UDI-Public: 10705031006539
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: 11/30/2022
• Device Catalogue Number: 593H
• Device Lot Number: LPH106
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1