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ETHICON INC. SFX SPI PDS+ UNI VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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| Model Number SXPP1B412 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
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| Event Date 01/01/2022 |
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Event Type
Injury
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Event Description
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It was reported that a patient underwent a knee prosthesis on an unknown date and barbed suture was used.5 to 6 weeks after the procedure the patient experienced local skin reaction with scar disunity at different sites of the scars and expulsion of thread fragments.The suture would be at the origin of this reaction evoking an intolerance.The patient got a reoperation.This caused pain and unsightly scars.Additional information was requested.
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Manufacturer Narrative
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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.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.Component code: g07002 device not returned.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 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 will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index 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)? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? what tissue dehisced? is it known how the wound dehisced? did the sutures barbs not engage in the tissue? did the suture pull out of the tissue? did the suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating stress factors that led to the suture breaking or pulling out of the tissue? please describe the surgical intervention required for the wound dehiscence 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.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? product code and lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.
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Manufacturer Narrative
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Product complaint #
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> (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: d1, d2, d4, g1, g4 additional information: d4 ¿ the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: sgbjdm, shbbcz, rpbecb.
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Manufacturer Narrative
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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: ¿ what was the diagnosis and indication for the initial procedure? gonarthrosis.Total knee prosthesis ¿ what was the initial approach for the initial procedure (open, laparoscopic or other)? opened ¿ what tissue was the suture used on? subcutaneous ¿ what was the state of the tissues (normal, thin, calcified, fragile, diseased)? normal ¿ was the fixation tab pressed against the tissue at the start of suture use? no tab with this yarn ¿ were two reverse stitches performed on the incision prior to closure? yes ¿ do we know how the wound broke up? intolerance - allergy ¿ did the stitches not engage the tissue? no ¿ did the suture break? if yes, where was the break noted (termination, middle, end)? no ¿ were there any precipitating stressors that led to suture failure or tissue tearing? no ¿ could you provide us with more information on the surgery required for wound dehiscence, including date and results.? ¿ did the operating surgeon observe a defect or anomaly in the sutures before, during, after placing the sutures or during a re-operation? no ¿ what is the physician's opinion of the etiology or contributing factors to this event? allergy - intolerance to yarn ¿ what is the patient's current condition? i'm fine but disgraceful scar.
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Manufacturer Narrative
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Product complaint #
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> (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: d9, h3 investigation summary
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> the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received, one open box with eight unopened samples that pertain to product code sxpp1b412, lot shbbcz.Visual analysis of the returned sample determined that it was received, two sealed boxes with twelve unopened samples each that pertain to product code sxpp1b412, lot rpbecb.Visual analysis of the returned sample determined that it was received, two boxes as total twenty-four unopened samples that pertain to product code sxpp1b412, lot sgbjdm.In order to evaluate the condition of the returned samples, the packets was examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured) and none was observed.The packets were opened, and the swage and attachment area were noted to be as expected.During the visual inspection the sutures were correctly placed on winding former.Sutures were dispensed without problem and examined along of the strand and no anomalies or damaged on suture surface could be observed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following: as a absorbable device, stratafix spiral pds plus may act transiently as a foreign body.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information: d4, h4 ¿ the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: sgbjdm - mfg.Date: 06/28/2022 expiry date: 05/31/2024 shbbcz - mfg.Date: 07/08/2022 expiry date: 06/30/2024 rpbecb - mfg.Date: 12/18/2021 expiry date: 11/30/2023 the device history records for the possible batch numbers were reviewed and the manufacturing criteria were met prior to the release of this lot.
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