MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 18IN 4-0 SA PS1 PR MP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B115
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: how many procedures are involved in this complaint? for each procedure, please provide: event date, quantity involved, lot number? it was unknown how many patients were involved.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.It was reported that the barbed suture product is more like a bump and less like a barb.It does not close tissue or slide through well because of its design.There were no bad outcomes as a result of this trial with barbed sutures.It was stopped abruptly because it had potential for harmful complications to our patients.

• Brand Name: SFX SPI MCRYL+ UNI 18IN 4-0 SA PS1 PR MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8963246
• Report Number: 2210968-2019-86550
• Device Sequence Number: 14094050
• Product Code: GAM
• UDI-Device Identifier: 10705031236769
• UDI-Public: 10705031236769
• Combination Product (Y/N): N
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: No Information
• Device Catalogue Number: SXMP1B115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/04/2019
• Patient Sequence Number: 1