MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE
Health Effect - Clinical Codes	Bradycardia (1751); Erythema (1840); Extreme Exhaustion (1843); Fever (1858); Inflammation (1932); Pain (1994); Swelling (2091)
Date of Event	12/04/2020
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 that the patient was transferred from on hospital to another for ligament stabilisation at the elbow.During the procedure the patient was treated with two pushlock biocomposite 3,5mm and a fibertape.Postoperative the patient conditions got intermittently worse.The patient complaint about having a little pain, fever and is feeling exhausted.It was further reported that the heart performance decreased to 45%.Other signs of inflammation such as swelling, redness and heat are not present according to the medical staff.The patient was diagnosed but so far no cause could be found therefore the hospital assumes that the allergic reaction was caused by the fibertape.The patient is currently treated conservatively.

• Brand Name: FIBERTAPE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11046854
• Report Number: 1220246-2020-02426
• Device Sequence Number: 13751581
• Product Code: GAT
• UDI-Device Identifier: 00888867120938
• UDI-Public: 00888867120938
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: FIBERTAPE
• Device Catalogue Number: AR-7237-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other