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

Catalog Number	SXPP1A402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	01/01/2019
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.The patient demographic info: age, weight, bmi at the time of index procedure.What tissue type and location of the suture placement? what tissue dehisced? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? was the fixation tab intact when the suture was placed in the patient? what date did the patient present with dehiscence (# post op days)? can you describe the appearance of the stratafix suture during second procedure? other relevant history patient history / concomitant medications lot number, if applicable, will representative product of the lot number be returned, return date, tracking information? what is the 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 the patient underwent c-section on (b)(6) 2019 and barbed suture was used.Post operatively, the seating tab came loose and the device unraveled.This caused a wound dehiscence.The patient was re-operated on (b)(6) 2019 to address the issue.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).The following additional information was obtained: the surgeon was not certain that the procedure date was (b)(6) 2019.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/29/2019.Additional information: a2, a3, b7, d3, g1, g2 corrected information: b3 additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure -32 y/o, bmi 29 what tissue type and location of the suture placement? -fascia of pfannensteil incision what tissue dehisced? -yes this was found 6 weeks later what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? -normal, appropriately thin given pregnant state was the fixation tab intact when the suture was placed in the patient? -yes what date did the patient present with dehiscence (# post op days)? -45 can you describe the appearance of the stratafix suture during second procedure? -no second procedure performed yet.Dehiscence found clinically and on ct imaging other relevant history patient history / concomitant medications lot number -unknown if applicable, will representative product of the lot number be returned, return date, tracking information: - will try and track down what is the physician¿s opinion as to the etiology of or contributing factors to this event? -incorrect training on how to secure the fixation tab what is the patient¿s current status? -surgeon is planning surgery to fix the dehiscence but is stable 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.Please clarify: -procedure date.-date of dehiscence.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX
• 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: 9130395
• Report Number: 2210968-2019-88177
• Device Sequence Number: 16738375
• Product Code: NEW
• UDI-Device Identifier: 10705031218741
• UDI-Public: 10705031218741
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1A402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 11/20/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/29/2019; 11/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR