MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.It was reported the device is not available to return for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that a patient experienced an adverse reaction after having ar-2290, proximal tenodesis implant system (lot: 10261466) implanted during an initial proximal bicep tenodesis procedure.The rep stated they were not present during the procedure.Additional information has been requested.Additional information received on (b)(6) 2019: the rep confirmed the patient started experiencing intermittent erythema of the shoulder, neck, face, and chest, swelling of the upper arm, and pain of the shoulder one week post-op.The patient's symptoms are being treated with nsaids, prednisone, benadryl and keflex.Cultures were not taken.Skin patch testing was performed, and the patient tested positive for titanium sensitivity.A revision procedure has been scheduled to take place on (b)(6) 2019 at the same facility, and will be performed by the same surgeon.Additional information received on (b)(6) 2019: the rep reported the proximal button that came within the ar-2290, proximal tenodesis implant system (lot: 10261466) was explanted during the revision procedure that took place on (b)(6) 2019.No additional arthrex parts were implanted during the revision.The surgeon stitched the bicep with suture to soft tissue.The rep confirmed the explanted implant is not available to return for evaluation.An arthrex representative was not present during the revision procedure.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 8734294
• MDR Text Key: 149258043
• Report Number: 1220246-2019-01160
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Device Lot Number: 10261466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other