MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number ZB347

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date and suture was used.The patient experienced an early, deep seroma with suture line disruption and return to the or.He did not feel like the wound was infected.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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.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 provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? is it known how the wound dehisced? did the sutures untie, break, or pull out of the tissue? were there any precipitating stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days).Please describe any surgical intervention required, including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: unable to return affected suture.Acct staff inadvertently discarded the suture to be returned.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? over the last 6 weeks.Posterial cervical fusions or lumbar fusions the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? pds suture was used on the fascia.Stratafix used on the sub q tissue what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? fascial dehiscence.The dehiscence was a hole the size of an eraser head.Is it known how the wound dehisced? did the sutures untie, break, or pull out of the tissue? the suture breaks and is gone were there any precipitating stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days) 2-3 weeks post op the suture breaks and is gone please describe any surgical intervention required, including date and findings.Patients were taken back to the or.Pds was used.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.Broken what symptoms did the patient experience following the index surgical procedure? onset date? collection of serous fluid in the sub q 2-3 weeks post op other relevant patient history/concomitant medications? yes, patients had history of obesity, diabetes, etc.What is the physician¿s opinion as to the etiology of or contributing factors to this event? he thinks it was a bad batch.Is not seeing this problem after reoperation or on new cases.He is no longer using stratafix.What is the patient's current status? healing.Everyone is doing well now.If applicable, will product be returned? if so, please provide the return date and tracking information.No.Additional information was requested, and the following was obtained: sales rep clarified that only pds suture was used on this patient.Sales rep stated that it is possible that there could be other contributing factors that led to these events.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Corrected information: h6- medical device problem code corrected information: h6-type of investigation.

• Brand Name: PDSII VIO 36IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15951230
• MDR Text Key: 305178202
• Report Number: 2210968-2022-10173
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031062054
• UDI-Public: 10705031062054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZB347
• Device Catalogue Number: ZB347
• Device Lot Number: RGMHSZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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