MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 5IN2 USP3-0 D/A X-1; STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXPP2B102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a tha : total hip arthroplasty on an unknown date and a barbed suture was used.About three weeks post-op, it was found that the suture protruded from a distal tha.The protrusion part was excised and treatment was done.After that, there has been no problem.Two weeks postoperatively, the superficial coating material was removed.Additional information was requested.
Additional 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.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 of index surgical procedure? on what tissue was the suture used? 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? please describe any medical/surgical intervention required for this suture event including dates and results.The event stated ¿the protrusion part was excised and treatment was done.¿ what treatment was done? please provide specifics.Please clarify the statement ¿the superficial coating material was removed¿.Please provide further details.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure, if applicable? 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? what is the patient's current status? lot number?.
Additional 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.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¿ date of index surgical procedure?¿total hip arthroplasty on what tissue was the suture used?¿dermis what was the tissue condition (normal, thin, calcified, fragile, diseased)?¿not reported 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 please describe any medical/surgical intervention required for this suture event including dates and results.¿excision suture only the part of protruded the event stated ¿the protrusion part was excised and treatment was done.¿ what treatment was done? please provide specifics.=> it means that the protrusion part was excised.Please clarify the statement ¿the superficial coating material was removed¿.Please provide further details.¿removal of dressing did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?¿no did the stratafix suture break? if so, where was the break noted (termination, middle, end)?¿no can you describe the appearance of the stratafix suture during second procedure, if applicable?¿not performed second operation what symptoms did the patient experience following the index surgical procedure? onset date?¿suture protrusion other relevant patient history/concomitant medications?¿unk what is the physician¿s opinion as to the etiology of or contributing factors to this event?¿unk what is the patient's current status?¿no trouble lot number?¿unk.

• Brand Name: SFX SPI PDS+ BI VIO 5IN2 USP3-0 D/A X-1
• Common Device Name: STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE
• 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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18395366
• Report Number: 2210968-2023-10149
• Device Sequence Number: 2748346
• Product Code: NEW
• UDI-Device Identifier: 10705031465220
• UDI-Public: 10705031465220
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K192144
• 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
• Report Date (Section B): 01/05/2024

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: SXPP2B102
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/05/2024
• 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