MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
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.Attempts have been made to retrieve the device.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 via: fixation tab or loop breakage during the procedure or barbs are missing and not holding in the tissue during the procedure? loop was broken.Do you have a picture for visual analysis? yes, have attached a picture.Was needle removed from the patient? needle did not go in the patient.Any additional tissue dissection damage due to searching for needle? no, the needle did not break inside the patient.It broke when they grabbed it with the needle driver.What was the size of the needle used? ct-2.Was more than half the needle retained in the patient? no needle in patient lot number? no.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.Events reported: 2210968-2022-03277 and 2210968-2022-03278.
Event or Problem Description
It was reported that a patient underwent a spine procedure (b)(6) 2022 and barbed suture was used.During the procedure, multiple sutures had 'needles breaking in half and ends not holding.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14286585
• Report Number: 2210968-2022-03276
• Device Sequence Number: 1519704
• Product Code: GAM
• UDI-Device Identifier: 10705031236608
• UDI-Public: 10705031236608
• Combination Product (Y/N): Y
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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
• Device Model Number: SXMP1B109
• Device Catalogue Number: SXMP1B109
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown