MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE® TENDON COMPRESSION BRIDGE KIT; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	AR-7297
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/02/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported through the clindex system that the patient experienced an adverse event.Additional information provided 11/08/2021: on (b)(6) 2021, it was reported the scab fell off the incision.(2cm x 3 cm wound, approximately 1/4 inch in depth).A wound culture was sent (negative).Patient was advised to have daily wound dressing changes by home health.Patient returned to clinic on (b)(6) 2021 for a recheck, and wound was opened (8-10cm, depth 1cm).Patient was advised to continue wound care.On (b)(6) 2021 patient returned for an office visit, and the wound was (12cm x 2 cm x 1.5cm), and planned for surgical debridement.On (b)(6) 2021 patient was admitted for surgical debridement.Wound was (16cm x 7 cm x 3cm), and a wound vac was placed.A wound culture sent- (b)(6), and still considered to be superficial.On (b)(6) 2021 the wound culture result was (b)(6), and the patient was seen in office on (b)(6) 2021 with hh to do daily dressing changes.On (b)(6) 2021 patient was taken to the or for debridement.During this procedure the surgeon debrided down to sternum and the fibertapes were removed.The patient is considered to have a deep wound infection, and is greater than 30 days post-op.Patient was discharged with wound vac and hh.Additional information provided 11/12/2021: ar-7297, lot: 12116522 was explanted from the patient on (b)(6) 2021.Device will not be returned.

• Brand Name: FIBERTAPE® TENDON COMPRESSION BRIDGE KIT
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12896308
• Report Number: 1220246-2021-04010
• Device Sequence Number: 14428141
• Product Code: GAT
• UDI-Device Identifier: 00888867289086
• UDI-Public: 00888867289086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: AR-7297
• Device Catalogue Number: AR-7297
• Device Lot Number: 12116522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/30/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown