MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP945H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a knee or hip surgery on an unknown date and suture with a ps1 or ct1 needle was used.The patient presented with suture spitting between week 4 and 8.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.H6 component code: g07002 device not returned d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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.Additional information was requested, and the following was obtained: * please confirm the number of patients affected by this issue.6 patients.Occurred in both (¿knees and hips 4- weeks after surgery) 6 if possible, please provide the following information for each patient/event: ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.I do no ¿1 patient¿.Patient removed suture on their own¿.1 or 2 brought back to or to remove¿ ¿ can you identify the product code and lot number of the product that was used? ¿they think they can retrieve¿ ¿ if medication was required, please clarify if it was prescription strength.¿yes antibiotics that were prescribed¿ was there any alleged deficiency with the device no ¿ what is the most current patient status? ¿one was infected, the rest resolved¿ ¿ what is the procedure date (dd/mm/yyyy)? there were 6 procedures, i don¿t have the dates because of the 4-6 weeks after post op occurrences ¿ what date did the suture spitting occur on (dd/mm/yyyy)? 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.Name of suture used.Product code and lot number? patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? how was the suture originally tied (multiple knots, square knot, etc.)? please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection from the initial surgical procedure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? please describe any medical intervention performed including medication name and results.Were any pre-op cleansing procedures changed recently? if yes, please describe other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
Additional Manufacturer Narrative
Product complaint # (b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information: d1, d2a, d2b, d4-catalog, d4 udi, g4.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was requested, and the following was obtained: i received information today through a phone call with the sales rep that the products used in these procedures are mcp945h and y266h.

• Brand Name: MCRYL+ UD 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22318637
• Report Number: 2210968-2025-07294
• Device Sequence Number: 8857541
• Product Code: GAM
• UDI-Device Identifier: 10705031046795
• UDI-Public: 10705031046795
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: MCP945H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown