MAUDE Adverse Event Report: ARTHREX, INC. FW BPB #2 SUTR,BLU W/NDL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FW BPB #2 SUTR,BLU W/NDL
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling (2091); Discharge (2225)
Date of Event	05/17/2019
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.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the patient that he had surgery on (b)(6) 2019 to repair a torn achilles tendon using arthrex fiberwire sutures.Approximately 6 weeks post op the patient began experiencing pain, swelling and oozing near the surgical site.The patient tested positive for staph infection and has been treated with antibiotics.The issues continue to come back and he continues to be treated with antibiotics on and off each time the symptoms reappear.The patient's allergist has requested that he obtain the material composition of the implants and has requested that a sample of the product be provided to the allergist for patch testing to determine if the patient may be allergic to the implant materials.At time of initial report the patient did not know the actual arthrex product number but will obtain it and provide to arthrex.Additional information obtained 02/04/2020: the patient has reported that he had second surgery on (b)(6) 2019 at a different facility by a different surgeon than the original procedure.During the second procedure the surgeon removed the fiberwire from the patient.During debridement the surgeon took tissue samples which were sent to the lab.The samples tested positive for staph infection.Patient believed the infection was most likely contracted during the first surgery at the original surgical facility.Patient had requested that some of the fiberwire be kept to return to arthrex for evaluation however the facility had notified him that the product was destroyed.Post surgery the patient was treated for staph infection with 10 weeks of antibiotics, including 3 weeks intravenously through a picc line.As of (b)(6) 2020 patient is off of the walking boot and working on physical therapy on his ankle.Patient still walks with a limp but it is slowly progressing and patient states he is hopeful for a full recovery.There is no sign of recurring infection to date and he has been off antibiotics about 3 weeks at time of this update.The incision has healed nicely.Patient was unable to obtain the specific fiberwire part number that was used during his original procedure because the facility does not record sutures used during procedures.Using the original surgical facility's purchases over the course of one year arthrex has determined the most likely part number to be ar-7202.

• Brand Name: FW BPB #2 SUTR,BLU W/NDL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9750591
• Report Number: 1220246-2020-01694
• Device Sequence Number: 2855660
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: 00888867041264
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: FW BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other