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).A manufacturing record evaluation was performed for the finished device lot number qbmhsz, and no non-conformance's related to the reported complaint condition were identified.Investigation summary : it was reported that six weeks post op of a hip surgery, the patient had necrotic tissue long the suture line.Two opened boxes with a total of seven-teen unopened samples of product code y497g, lot # qbmhsz were returned for analysis.The complaint sample was not received for evaluation.Thirteen unopened sample was examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packets were opened, and the swage and attachment area were noted to be as expected.During the visual inspection the sutures were correctly placed on winding former.Sutures were dispensed without problems and examined along of the strand and no defects, damaged on suture or surface could be observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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# 2210968-2020-07109.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.

• 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: 10556629
• Report Number: 2210968-2020-07108
• Device Sequence Number: 2445412
• 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
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: Y497G
• Device Catalogue Number: Y497G
• Device Lot Number: QBMHSZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention