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).(b)(4).A manufacturing record evaluation was performed for the finished device qbmhsz batch number, and no non-conformances were identified.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# 2210968-2020-07098.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: 10556655
• Report Number: 2210968-2020-07097
• Device Sequence Number: 3749756
• 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?: No
• 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