MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	01/09/2019
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 therefore the complainant's event could not be verified.The device remains in the patient.The root 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.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported that approximately one month and a half after having a primary btb acl autograft procedure performed, the patient started experiencing swelling of the hands, feet, and face with a reported increased level of pain on the operative knee.The original procedure took place on (b)(6) 2019.The rep confirmed there are no signs of infection, and no signs of increased swelling around the operative knee.The rep stated there is not a revision procedure scheduled at this time.The following arthrex parts were implanted during the original procedure, and remain implanted in the patient: ar-1380c // lot: 1023538 // qty.: 1.Ar-1380c // lot: 1024227 // qty.: 1.Ar-2324bcc // lot: 1020860 // qty.: 1.Additional information received on 3/14/2019: the facility confirmed that the patient is not being treated with any medications at this time.The patient was advised by their primary physician to monitor symptoms.The facility is sending to have allergy testing done.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8456852
• Report Number: 1220246-2019-00987
• Device Sequence Number: 3013895
• Product Code: MAI
• UDI-Device Identifier: 00888867015272
• UDI-Public: 00888867015272
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1380C
• Device Lot Number: 1024227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/27/2019
• 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