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

Model Number SXPP1A406

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).Attempts are being 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.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained: 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? unk what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? laparoscopic.On what tissue was the suture used? myometrium of uterus.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? yes.Were two reverse stitches performed across the incision prior to closure? yes.What instruments were used to grasp the needle? -needle holder.Where was the needle grasped during use? in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end.What was the size of the broken needle fragment? unk.Was it just the tip of the needle that fell into the patient? yes.Were the needle piece(s) retrieved during the same procedure? no.Does the piece/device remain retained in the patient's tissue? yes.If the piece(s) were retained, where are they located/in what structure? unk.If retained, were there any patient consequences? no.If retained, are there plans for removal of any remaining fragments? unk.Was the needle tip seen on the x-film and b ultrasound? no.Please describe any medical/surgical intervention required for this suture event including dates and results.B ultrasound and ct was used to locate the needle tip again several days after the op.What was the reason for the 4-5 hour extension of the procedure? position the broken needle tip.Was the surgeon looking for the needle piece during the entire 4-5 hour procedure extension? yes.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.No.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? not until now.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the product issues.What is the patient's current status? good.If applicable, will product be returned? if so, please provide the return date and tracking information.Yes.The product was received at local facility and will return to franchise.

Event Description

It was reported that a patient underwent a laparoscopic myomectomy on (b)(6) 2022 and a barbed suture was used.During the procedure, the needle tip was fractured and remained in the tissue when suturing the myometrium of uterus.The x-film and b ultrasound were used to position the needle tip but it was not found.The surgery was extended by about 4-5 hour.The procedure was completed with a new product.

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/6/2022 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: h6 additional h3 investigation summary: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows a broken needle at the tip product code sxpp1a406.Unfortunately the photo does not provide enough evidence to determine the root cause.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/17/2023.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 h3 investigation summary: the product received for analysis was identified as product code sxpp1a406.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.As part of ethicon¿s quality process every product is 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.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; col salvacar; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15868156
• MDR Text Key: 304331354
• Report Number: 2210968-2022-09776
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227675
• UDI-Public: 10705031227675
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SXPP1A406
• Device Catalogue Number: SXPP1A406
• Device Lot Number: SBMEMJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other