MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 2-0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP839D
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013); Fluid Discharge (2686)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.Additional information was requested, and the following was obtained: - was there any adverse consequence associated with the patient? (b)(6) 2023 rehab documented s/s of infection noted along incision.(b)(6) 2023 two areas approximately 0.5cm near the middle and cephalad aspect of the incision with superficial dehiscence, no active drainage, minimal erythema.No fluctuance or significant tenderness, mild serosanguineous with spotting on the dressing, no purulent discharge.Rx clindamycin due to depends covers wound, + mrsa screen and was referred to wound care.(b)(6) 2023 debridement subcutaneous tissues with serosanguinous drainage.No purulence erythema or induration."i do feel this is merely a reaction to the dissolvable sutures and her body rejecting, there is inflammation but there is no infection".(b)(6) 2023 no signs or symptoms of infection documented; wound debridement.What is the current status of the patient? following with wound care for non-healing surgical wound.Was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.(b)(6) 2023 wound debridement to the subcutaneous tissue; serosanguinous drainage.(b)(6) 2023 wound debridement; serosanguinous drainage.If product was removed: unknown from documentation if sutures were removed.What was the appearance of the suture during the removal? n/a.If re-suture/re-closure was performed: no.Was reoperation necessary to remove the suture and re-close the wound? no.Was the suture trimmed in physician¿s office? no.Was the suture removed in a routine post-op procedure? post-op office visit staples removed from skin.Was the suture removed in a reoperation procedure? no.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.(b)(6) 2023 clindamycin 150mg capsule: take 1 capsule po qid for 14 days.(b)(6) 2023 clindamycin 150mg capsule: take 1 capsule po qid for 7 days.What was the name of the procedure? lumbar 4-lumbar 5 posterior spinal instrumented fusion and decompression.What was the procedure date? (b)(6) 2023.Please provide the lot number: unknown lot numbers.Supply number: sxpp1a205-suture statafix 1, vcp839d-suture vicryl plus 2-0 & vcp840d-suture vicryl 0 ct-1.Event related to mw # 2210968-2023-05536, mw # 2210968-2023-05538.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 472 g/m.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
It was reported that a patient underwent a lumbar 4-lumbar 5 posterior spinal instrumented fusion and decompression procedure on (b)(6) 2023 and suture was used.Post op the sutures were not dissolving and were being rejected.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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: age, gender, weight, bmi at the time of index procedure 68f, 102.5kg, 36.3 what was the tissue condition (normal, thin, calcified, fragile, diseased) normal.For vicryl suture- how was the suture placed (interrupted or continuous)? interrupted.For vicryl suture - how was the suture originally tied (multiple knots, square knot, etc.)? not documented.For stratafix symmetric pds plus - was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? unknown only documented "fascia closed using a running 1-0 stratafix suture".For stratafix symmetric pds plus - were two reverse stitches performed across the incision prior to closure? unknown.What tissue layer(s) dehisced? subcutaneous.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no documentation or reports of issues.Other relevant patient history/concomitant medications? n/a.What is the physician¿s opinion as to the etiology of or contributing factors to this event? wound care provider documented, "i do feel this is merely a reaction to the dissolvable sutures and her body rejecting, there is inflammation but there is no infection".Corrected information: h6 type of investigation.Corrected: information: h6 health effect - clinical codes.

• Brand Name: VCL+ UD 8X18IN 2-0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17440525
• Report Number: 2210968-2023-05537
• Device Sequence Number: 11412486
• Product Code: GAM
• UDI-Device Identifier: 10705031055766
• UDI-Public: 10705031055766
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Catalogue Number: VCP839D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 102 KG