MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J397H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Not Applicable (3189)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mk2941 / j397h45, and no non-conformances were identified.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 on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were both devices j345h and j397h involved in the event where the suture broke post-op and incision split? was there any precipitating stress factor for the sutures breakage post-op? other relevant patient history/concomitant medications.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? investigation summary: an unopened sample of product code j397h, lot mk2941 was returned for evaluation.The complaint sample was not received for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative sample, no breakage suture post-op was found and the tested sample met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent lateral episiotomy on (b)(6) 2019 and suture was used.Eight days after the surgery, the suture broke and the incision split.The wound had pus but with no inflammation and no erythema.The patient was treated with removal of the suture, debridement, and a sitting bath with potassium permanganate twice a day.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/08/2020.Additional information: a2.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure--------32 years old, other information is unk.On what tissue was the suture used?-----unk.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased?-----normal were both devices ¿ j345h and j397h ¿ involved in the event where the suture broke post-op and incision split?-----yes, both sutures were broken.Was there any precipitating stress factor for the sutures breakage post-op?-----unk.Other relevant patient history/concomitant medications -----unk.What is physician¿s opinion as to the etiology of or contributing factors to this event?-----incision dehiscence occurred.The physician considered that the suture did not have enough tension.What is the patient¿s current status?-----the patient had recovered.Note: events reported via mw # 2210968-2019-90522, 2210968-2019-90523.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9410532
• Report Number: 2210968-2019-90522
• Device Sequence Number: 1834690
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• 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): 11/13/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: J397H
• Device Lot Number: MK2941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR