MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 90CM M3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	F2431H
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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.Lot #? any patient consequences/ae outcome as a result of the event report? was there any medical/surgical intervention done on patient post-op to remove the broken suture from patient body? patient current condition?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.At the ablation of the suture, the thread did not slide and that led to a breakage of the thread.A part of the thread stayed under the skin of the patient.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: ETHILON BLK 90CM M3
• 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: 8565065
• Report Number: 2210968-2019-80826
• Device Sequence Number: 14262116
• Product Code: GAR
• UDI-Device Identifier: 10705031237711
• UDI-Public: 10705031237711
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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 Catalogue Number: F2431H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1