MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Not Applicable (3189)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 provided: the abscess developed in the tab part especially.("anchor" is wrong, correct word is "tab") and there was a possibility that end of the sutured part was knotted without back-stitch.An abscess was detected when the patient was re-admitted.Specific symptoms are unknown.Treatment was withdrawn, wound washing, antibiotic administration.It is unknown whether it was re-sutured.Whether or not to be re-hospitalized is unknown.Attempts are being made to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.What was the condition of the tissue where stratafix suture was used (normal, diseased, weakened)? where did the suture start (top to bottom or bottom to top)? when suturing with stratafix symmetric, how far was the bite from the edge of the tissue? were any solutions used during closure (ie antimicrobial)? can you describe the patient initial symptoms of the abscess? were cultures performed of the wound? what were the results of the cultures? what is the surgeon opinion as to relationship of the stratafix suture and the patient dehiscence? what was the date of the second procedure? can you describe the appearance of the suture during the second procedure? can you identify the lot number of the stratafix sxpp1a409 suture used? do you have the status of suture for evaluation? what is the current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent craniotomy brain tumor resection procedure on (b)(6) 2018 and barbed suture was used during closure.The patient was discharged (b)(6) from the facility.The patient experienced unknown symptoms and was diagnosed with an abscess on unknown date and wound dehiscence.A second procedure was performed on unknown date between (b)(6) and (b)(6).The surgeon reported that the abscess developed on the tab portion of the suture.The suture was removed and it is unknown how the procedure was completed.The patient received antibiotics and is reported as not getting worse.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018 additional information: additional information was requested and the following was obtained: what was the condition of the tissue where stratafix suture was used (normal, diseased, weakened)? =>no information.Where did the suture start (top to bottom or bottom to top)? =>no information.When suturing with stratafix symmetric, how far was the bite from the edge of the tissue? =>no information.Were any solutions used during closure (ie antimicrobial)? =>no information.Can you describe the patient initial symptoms of the abscess? =>although the initial symptoms of abscess are unknown, an abscess was found when a patient was visited on (b)(4).Were cultures performed of the wound? =>no information.What were the results of the cultures? =>na what is the surgeon opinion as to relationship of the stratafix suture and the patient dehiscence? => ""if the patient was recovered by removing the suture, there is a possibility that the suture caused this event.But, if a vicryl plus was used as in the past, there is a possibility that the surgical site infection occur with a fixed probability, so there was a possibility that it happened by chance."" what was the date of the second procedure? => the reoperation day is between (b)(4) and (b)(4).Can you describe the appearance of the suture during the second procedure? =>no information.Can you identify the lot number of the stratafix (b)(4) suture used? =>the lot number is unknown.Do you have the status of suture for evaluation? =>no sample will be returned.What is the current condition of the patient? =>the patient go to hospital regulary and being followed-up.

• Brand Name: SFX SYM PDS+ VIO 18IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8079183
• Report Number: 2210968-2018-77200
• Device Sequence Number: 1691767
• Product Code: NEW
• UDI-Device Identifier: 10705031227729
• UDI-Public: 10705031227729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: SXPP1A409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention