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
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	11/26/2020
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 a patient developed a tibial cyst after an anterior cruciate ligament repair.No further information received.Update 01-dec-2020: further information were provided that the initial surgery was performed on (b)(6) 2019 and that the reported problem was identified on (b)(6) 2020.It was further reported that the patient was treated conservatively and had persistent pain.

• 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: 11003970
• Report Number: 1220246-2020-02406
• Device Sequence Number: 3813800
• Product Code: MAI
• UDI-Device Identifier: 00888867015272
• UDI-Public: 00888867015272
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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 Expiration Date: 04/30/2021
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1380C
• Device Lot Number: 10314867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other