MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI UD 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B414
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a total knee replacement procedure on (b)(6) 2022 and barbed suture was used.During use, while in a total knee replacement and using suture, the needle popped.There were no adverse consequences for the patient.One device will be returned.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated?u nknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please clarify what do you mean by "the needle popped off on five different occasions"? sales rep stated this was one procedure with multiple needle pop offs.Did this issue occur in one single procedure? or this occurred in multiples procedures? please clarify sales rep stated this was one procedure with multiple needle pop offs.What is the lot number? unknown.Device return follow up: device available for return.Shipper kit requested.Note: related events reported on mw# 2210968-2022-10143, mw# 2210968-2022-10144, mw# 2210968-2022-10147, and mw# 2210968-2022-10148.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 gm all others.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.

• Brand Name: SFX SPI MCRYL+ UNI UD 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15949053
• Report Number: 2210968-2022-10145
• Device Sequence Number: 20658757
• Product Code: GAM
• UDI-Device Identifier: 30705031236404
• UDI-Public: 10705031236400
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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 Model Number: SXMP1B414
• Device Catalogue Number: SXMP1B414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown