MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on an unknown date and barbed suture was used with continuous suture.After the surgery, when the patient's wound was checked in the ward, the dermal suture was broken and wound dehiscence occurred.In the ward, the dermis was re-sutured with one or two stitches.No further treatment plan.The surgeon re-stitched it and it healed fine.The patient has been discharged from the hospital.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.Trade name - irgacare®; active ingredient(s) ¿ triclosan; dosage form ¿ suture/solid/parenteral; strength ¿ = 2360 g/m.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.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.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? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? where was the break on the stratafix noted (termination, middle, end)? were there any patient stress factors that precipitated the event of suture breakage post op? onset date/time of dehiscence? (# post op days).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.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? lot number?.
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: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure¿ demographic information is not available.Date and name of index surgical procedure?¿total knee arthroplasty, tka, about 1 week before the alert date.The diagnosis and indication for the index surgical procedure? ¿total knee arthroplasty, tka.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)?¿open what was the tissue condition (normal, thin, calcified, fragile, diseased)?¿we did not obtain any information that the patient had a special condition.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure?¿yes was at least one reverse stitch performed prior to closure?¿yes where was the break on the stratafix noted (termination, middle, end)?¿middle of the stratafix.Were there any patient stress factors that preceipitated the event of suture breakage post op?¿no onset date/time of dehiscence? (# post op days) ¿ within 1 week after surgery.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?¿no please describe the appearance of the suture during the second procedure.¿multiple 1-2 stitch length separations were observed at the nodes.What symptoms did the patient experience following the index surgical procedure? onset date? ¿after the surgery, when the patient's wound was checked in the ward, the dermal suture was broken.Other relevant patient history/concomitant medications?¿no special information obtained.What is the physician¿s opinion as to the etiology of or contributing factors to this event?¿after experiencing this case, the surgeon used a competing product, v-lock, for finer stitches.
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: the procedure was tka :total knee arthroplasty.The suture breakage occurred at the center of the suture.The product was used in the way it was used.The breakage occurred within one week after the surgery.

• Brand Name: SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17142375
• Report Number: 2210968-2023-04362
• Device Sequence Number: 1894473
• Product Code: NEW
• UDI-Device Identifier: 10705031235984
• UDI-Public: 10705031235984
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K150670
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SXPP1B112
• Device Catalogue Number: SXPP1B112
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 08/10/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/26/2023; 08/28/2023
• 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 Sex: Unknown