MAUDE Adverse Event Report: ETHICON INC. 4-0 30CM STRATAFIX SPIRAL MONOCRYL PLUS; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B435
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Reaction (2414); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = >(b)(4).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.
Event or Problem Description
It was reported that a patient underwent hand surgeon on (b)(6) 2017 and barbed suture was used on subcutaneous tissue and skin.Post operatively, the patient experienced wound dehiscence within 3 weeks of the procedure.The surgeon reported the device lost fixation strength.The surgeon opined that the coating on sutures led to poor fixation and what seemed to be a reaction and release of healing tissue.An additional procedure was performed to re-approximate the wound on an unknown date with a different suture type.The patient is reported as fine.Additional information will be requested.

• Brand Name: 4-0 30CM STRATAFIX SPIRAL MONOCRYL PLUS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7243801
• Report Number: 2210968-2018-70690
• Device Sequence Number: 10793898
• Product Code: GAM
• UDI-Device Identifier: 10705031236462
• UDI-Public: 10705031236462
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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: SXMP1B435
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention