MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J269H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
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.Date of initial procedure.Procedure name.Which tissue was the suture used on? did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? was the suture package reprocessed or sterilized? how many days post -op was the suture spitting/non-absorption issue noted? was wound dehiscence noted? what medical/surgical intervention was provided? patient's gender, age, weight, medical/ surgical history & medicines used? patient's current condition.Lot number of the vicryl suture.Any representative samples of the same lot available for evaluation?.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and suture was used.Post-operatively, the absorbable sutures were not absorbing, and the sutures were "spitting through the skin".It is unknown how or if the patient was treated for this condition.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VICRYL SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7884819
• Report Number: 2210968-2018-75863
• Device Sequence Number: 1939776
• Product Code: GAM
• UDI-Device Identifier: 10705031038431
• UDI-Public: 10705031038431
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• 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): 08/23/2018

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 Catalogue Number: J269H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/18/2018
• Patient Sequence Number: 1