MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI UD 12IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B425
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Did the barbs fail to engage in the tissue? can the surgeon describe the appearance of the barbs during procedure? how was the procedure completed? could you please provide the lot number? event/procedure date? 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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name -(b)(4), active ingredient(s)  triclosan, dosage form  suture/solid/parenteral, strength  = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent a prostatectomy procedure in 2021 and barbed suture was used.During the procedure, it was reported by the rep during a simple prostatectomy the surgeon noticed that when he was performing the anastomosis the barbed suture is supposed to hold tight after passing through tissue but it was "back sliding", and not holding tight.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+ UNI UD 12IN 3-0 S/A RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11584447
• Report Number: 2210968-2021-02843
• Device Sequence Number: 2955854
• Product Code: GAM
• UDI-Device Identifier: 10705031236578
• UDI-Public: 10705031236578
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: SXMP1B425
• Device Catalogue Number: SXMP1B425
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1