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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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.Can you confirm the procedure was on (b)(6)? what was the name of the initial procedure? what was the date (3 weeks post op) that patient developed symptoms? what was the date of the second procedure? can you describe the appearance of the suture during the second procedure? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient¿s current status?.
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 has been 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: 7243742
• Report Number: 2210968-2018-70689
• Device Sequence Number: 11023618
• 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