MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A402
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.The following information was requested, but unavailable: please provide the patient's demographic information including 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? lot number? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? how was the suture originally tied (multiple knots, square knot, etc.)? 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? what was the tissue condition (normal, thin, calcified, fragile, diseased)? onset date/time of dehiscence? (# post op days).How was the dehiscence managed? please describe any medical/surgical intervention required for this suture event including dates and results.Please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Were there any precipitating stress factors for the wound dehiscence? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection from the initial surgical procedure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Please describe any medical intervention performed including medication name and results.What is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ug/m.
Event or Problem Description
It was reported the patient underwent a hip surgery on an unknown date and a barbed suture was used to close the fascia.Post-op, the suture did not hold in tissue and resulted in wound dehiscence and infection.The patient underwent a revision surgery.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary: a used suture piece was received for evaluation.Visual inspection was conducted on the returned sample.During the visual inspection of the sample received a used suture piece of three inches of length with body fluids and tissue at the surface, lineal cut at the ends, and damage that appears to be by the use of a surgical instrument could be observed.In addition, barbs were found damaged.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.Additional investigation summary: one packet of product code sxpp1a402 was returned to ethicon inc for analysis with the packaging closed.Upon initial inspection, of the sample, no external damages were observed on the packet.In order to evaluate the conditions of the returned sample, the sample was opened, and the needle-suture combination was placed correctly, the suture was dispensed without problems and examined along of the strand, and no defects, damage on the barbs could be observed and the fixation tab was intact.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: a manufacturing record evaluation was performed for the finished device qpmdlk- sxpp1a402 batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12983097
• Report Number: 2210968-2021-12523
• Device Sequence Number: 5261854
• Product Code: NEW
• UDI-Device Identifier: 10705031218741
• UDI-Public: 10705031218741
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 11/30/2022
• Device Model Number: SXPP1A402
• Device Catalogue Number: SXPP1A402
• Device Lot Number: QPMDLK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown