MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, BIOCOMPOSITE; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Health Effect - Clinical Codes	Erythema (1840); Swelling (2091)
Date of Event	08/03/2018
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 and remains in the patient.Therefore the complainant's event could not be verified.The 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.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported that on (b)(6) 2018 the patient underwent a carpal-meta carpal fascia arthroplasty with ligament reconstruction procedure where a biocomposite-tenodesis¿ screw 4 x 10 mm, ar-1540bc, was implanted.About 5 weeks post-op, the patient began to experience redness and swelling at the incision site.The patient was hospitalized and treated with iv antibiotics.The suture used in the surgery was from ethicon.Additional information has been requested.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7809849
• Report Number: 1220246-2018-00608
• Device Sequence Number: 11156492
• Product Code: HWC
• UDI-Device Identifier: 00888867018709
• UDI-Public: 00888867018709
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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 Expiration Date: 12/31/2019
• Device Model Number: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1540BC
• Device Lot Number: 10184576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other