MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLKC CLD 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number BIO-COMP SWVLKC CLD 4.75X19.1MM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Nausea (1970); Swelling (2091); Dizziness (2194); Numbness (2415); Post Operative Wound Infection (2446)

Event Date 06/06/2017

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.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It has been reported by the patient that on (b)(6) 2017 the patient underwent a right shoulder scope, rotator cuff repair subacronimal decompression, distal cavicle excision, bicep tenodesis and extensive debridement procedure.Patient reports he had a bad infection a few weeks after the (b)(6) 2017 procedure.Symptoms include swelling, pain and numbness in his right shoulder, dizziness/lightheaded, heavy feeling in eyes/face/chest, heart tightness, nausea, fatigue and all around sick feeling in his whole body.Patient also reports that his white blood cell count has been dropping since the surgery and is now in the low range.Patient had previously contacted arthrex on (b)(6) 2018 to inquire about the material composition of his implants which was provided to him ((b)(4)).At the time of the initial request for material composition the patient was questioned about any possible issues but did not report any to arthrex.Patient contacted arthrex again on (b)(6) 2018 requesting samples for patch testing be sent to his allergist/immunologist.When questioned again the patient did disclose having the above mentioned issues since his 2017 procedure.The following devices were implanted during the (b)(6) 2017 procedure: ar-2324bcc, biocomposite sweivelock, lot f132231 and ar-2324bct-2, biocomposite swivelock, lot 10073835.

• Brand Name: BIO-COMP SWVLKC CLD 4.75X19.1MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 7613988
• MDR Text Key: 111492909
• Report Number: 1220246-2018-00504
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: BIO-COMP SWVLKC CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: F132231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2017
• 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