MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 0 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z991G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4) to date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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, 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? product lot number? what was the tissue condition where pds suture were used, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? were there two sutures (z991g- pds) involved in this post-op event? please clarify what tissue dehisced and size of dehiscence? was there any precipitating stress factor for the complete wound dehiscence? did the operating surgeon observe any suture deficiency or anomaly before, during or after suture placement or during any re-operation? how was the dehiscence managed? if a surgical intervention was performed, provide date, findings or operation notes.Other relevant patient factors/comorbidities/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event ( complete wound dehiscence)? what is the patient¿s current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were 2210968-2020-09742 and 2210968-2020-09741.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.Post-operatively, the patient experienced complete wound dehiscence of an abdominal incision with each end of the fascia closure secured with a loop.Event occurred one week post-operatively.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 01/05/2021.Additional h6 component code: g07002 ¿ device not returned.The following information was requested, but unavailable: the patient demographic info: 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? product lot number? what was the tissue condition where pds suture were used, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? were there two sutures (z991g- pds) involved in this post-op event? please clarify what tissue dehisced and size of dehiscence? was there any precipitating stress factor for the complete wound dehiscence? did the operating surgeon observe any suture deficiency or anomaly before, during or after suture placement or during any re-operation? how was the dehiscence managed? if a surgical intervention was performed, provide date, findings or operation notes.Other relevant patient factors/comorbidities/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event ( complete wound dehiscence)? what is the patient¿s current status? 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.

• Brand Name: PDSII VIO 60IN 0 S/A TP-1 LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10972600
• Report Number: 2210968-2020-09741
• Device Sequence Number: 16761745
• Product Code: NEW
• UDI-Device Identifier: 10705031061996
• UDI-Public: 10705031061996
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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 Model Number: Z991G
• Device Catalogue Number: Z991G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1