MAUDE Adverse Event Report: ARTHREX, INC. 3-0 FW,18" BLU W/TPR NDL 15 MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	3-0 FW,18" BLU W/TPR NDL 15 MM
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Impaired Healing (2378)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The root cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
A patient reported that on (b)(6) 2018 she had undergone two different procedures on her right hand on different fingers.One procedure has had no issues.The right index finger which had the extensor tendon repair is not healing.The finger has had puss draining and has continually been having pieces of the sutures pushing out through the skin, with the most recent piece being approximately 2 inches long on (b)(6) 2019.Patient has been prescribed two courses of antibiotics.Patient developed colitis and c-diff from the antibiotics resulting in her having to go to the hospital.Patient has continued to soak her finger once per day and believes all pieces of the sutures may have now come out as the puss appears to have dissipated.Patient's only known allergy is iodine contrast.Part number was not known at the time of initial report.Additional information has been accepted.Additional information obtained (b)(6) 2019: the procedures performed on (b)(6) 2018 were right index finger primary tendon repair zone 5 and right middle finger extensor tendon centralization with reconstruction of the radial sagittal band.During the procedure the surgeon used arthrex 3.0 fiberwire.Specific part number unknown.Patient contacted facility who informed her that they do not keep an implant log for sutures.Patient had surgery on (b)(6) 2019 to remove the remaining fiberwire and clean out the area that would not heal.Additional information obtained (b)(6) 2019: patient states the second surgery on (b)(6) 2019 was a debridement of wound with removal of any remaining suture and tenolysis (release of adhesions).Surgeon did find some fiberwire still present at that time.The patient has confirmed with the facility that the facility does not keep an implant log for sutures.And therefore facility cannot confirm the specific arthrex suture product number that was used for this patient's (b)(6) 2018 procedure.Patient provided numerous pictures of her hand prior to second surgery.Sales rep has also confirmed with the facility that they do not record suture product numbers on their implant log.Additional information obtained (b)(6) 2019: patient provided pictures of her hand post the (b)(6) 2019 procedure to clean out the remaining fiberwire from her right index finger.Update 4/3/2019: using sales data of 3.0 fiberwire that has been purchased by the facility arthrex will report this incident using part number ar-7227-01 as the most likely part number based on this 3.0 fiberwire being the largest volume purchased by the facility.

• Brand Name: 3-0 FW,18" BLU W/TPR NDL 15 MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8526623
• Report Number: 1220246-2019-01040
• Device Sequence Number: 19314740
• Product Code: GAT
• UDI-Device Identifier: 00888867041561
• UDI-Public: 00888867041561
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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 Model Number: 3-0 FW,18" BLU W/TPR NDL 15 MM
• Device Catalogue Number: AR-7227-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other