MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y497G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Not Applicable (3189)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date of the index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the onset date of necrosis following the index surgery? did the patient experience an infection?-if yes, were cultures performed? results? date the debridement and reapproximation were performed? what was the appearance of the monocryl suture during the second procedure? where and how was the dermabond device used (what layer of tissue and how many layers applied)? was a dressing applied over the dermabond? if yes, please describe, including brand name.How many days post-op was the dressing in place? what was the frequency of dressing changes? has the patient had prior exposure to dermabond, prineo or skin adhesives? lot number of dermabond used other relevant patient history / concomitant medications? if applicable, will product be returned? what is the patient¿s current status? note: event related to topical skin adhesive reported via mw# 2210968-2020-07101.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a hip procedure on an unknown date and suture was used.It was reported that suture was used on cuticular layer and topical skin adhesive was used with aquacell dressing.Six weeks post-op, the patient had necrotic tissue along the suture line.The patient underwent debridement and re-approximation with nylon suture.There was no report of infection.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/14/2020.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device qbmhsz batch number, and no non-conformities were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MCRYL UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10556647
• Report Number: 2210968-2020-07100
• Device Sequence Number: 17081135
• Product Code: GAN
• UDI-Device Identifier: 10705031059399
• UDI-Public: 10705031059399
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2020
• Device Model Number: Y497G
• Device Catalogue Number: Y497G
• Device Lot Number: QBMHSZ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUILL DOUBLE ARMED SUTURE; VCL CT BRD UD 36IN 1 S/A CTX; VCL CT BRD UD 36IN 2-0 S/A CT-1
• Outcome Attributed to Adverse Event: Required Intervention