MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE; SUTURE - NON-ABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Inflammation (1932); Swelling (2091); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.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.Specific number of patients that had wound dehiscence relating to nylon suture? for each patient event please provide the following information: please provide specific product code and lot number involved.Please provide timelines of dates (initial procedure date, event date, reoperation date)? was there any evidence of suture breakage (nylon suture)? did the suture pull through the tissue? was the tissue condition compromised? what medical or surgical interventions were performed? how was the issue resolved? update to patient current condition.Patient demographics (initials, dob, bmi).Any product to return for analysis.

Event Description

It was reported that a patient underwent hip surgery on an unknown date and suture was used.The suture was possibly used on the skin and in the subcuticular layer.The patient possibly experienced dehiscence, swelling, discharge and inflammation.When the doctor cut the non-absorbable suture to open the wound he found a complete dehiscence of the deeper layers.Additional information has been requested.

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested and the following was obtained: the only thing that we are 100% aware of is that since we have stopped using all j&j sutures all have problems have gone away.We have not had one more wound breakdown.There were photos given to the reps when they were here as well, and there you can see what happened to the wounds.The majority were taken to theatre between 1-3 weeks post op for secondary suturing and the same goes for the secondary suturing that were done here in the rooms.Once the secondary suturing was performed then the wounds healed within 10 days or so.The swabs that we did take on random patients all came back negative.The other answers that we could answer is on your email below in red.Please provide timelines of dates (initial procedure date, event date, reoperation date)? the patients started notifying the rooms of wound problems between 1 - 4 weeks and secondary suturing was done immediately.Was there any evidence of suture breakage (monocryl suture)? yes.Was there any evidence of suture breakage (vicryl suture)? yes.Did the suture pull through the tissue? yes.Was the tissue condition compromised? yes.What medical or surgical interventions were performed? secondary suturing how was the issue resolved? secondary suturing.Update to patient current condition.Patient demographics (initials, dob, bmi).Any product to return for analysis was never requested.

• Brand Name: ETHILON NYLON SUTURE
• Type of Device: SUTURE - NON-ABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7455732
• MDR Text Key: 106383892
• Report Number: 2210968-2018-72318
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention