MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 2X27IN 2 S/A TP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J849G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.What do you mean by "the wire was brittle and without resistance" ? please explain in detail.Did the suture break into 2 pieces or fray? when reported event noticed/occurred? pre-op in package-before use on patient or intra-op during use on patient while suturing or post-op ?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the wire was brittle and without resistance.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Patient code: 3189 - surgical intervention.Additional information was requested and the following was obtained: we had a complication in a surgery, the patient performed the procedure on (b)(6) 2019, but last sunday (b)(6) 2019 it needed to return because he had evisceration.During the procedure surgeon found that vicryl wire was brittle and without resistance.He kept the wires removed from the patient for analysis if they wished.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: gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed, interrupted or continuous? how the suture was initially tied? please clarify the date that the patient experienced dehiscence: post-op 24 hours or (b)(6) 2019.It was reported that the suture was ¿brittle and without resistance¿.What was the appearance of the suture during the reoperation? was there an absorption issue with the device? if yes, please describe.Was the patient re-sutured during the reoperation? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/25/2019.Additional information was requested and the following was obtained: it was at first a colectomy in a colleague, professed free professor, that in the postoperative 24 the patient simply gutted and the vicryl thread was simply decomposed, a fact that should be intact for at least 90 days and open aponeurosis without shear signs which denotes the change in yarn quality.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.Did the suture break post-operatively? did the patient have a wound dehiscence? did the patient experience evisceration? was medical/ surgical intervention performed? if so, provide details.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 03/05/2020.Additional h3 device evaluation summary: multiples suture pieces of product code j849 were received for analysis.During the visual inspection of the sample, the suture was received in multiple pieces, present tissue and body fluids due to use.Three of the suture pieces were observed with multiples knots.Due to condition of the sample received no functional test could be performed.The product code j849 contains an absorbable suture and the time of exposure of suture to the environment could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the complaint could be confirmed, however the cause could not be determined.

• Brand Name: VCL CT BRD UD 2X27IN 2 S/A TP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9109889
• Report Number: 2210968-2019-88019
• Device Sequence Number: 19328786
• Product Code: GAM
• UDI-Device Identifier: 10705031043305
• UDI-Public: 10705031043305
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 08/28/2019

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: 10/31/2023
• Device Model Number: J849G
• Device Catalogue Number: J849G
• Device Lot Number: MM6770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 11/18/2019; 02/17/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/25/2019; 12/06/2019; 03/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention