MAUDE Adverse Event Report: ARTHREX, INC. BIO-TRANSFIX; FASTENER, FIXATION, BIODEGRADABLE

Model Number	BIO-TRANSFIX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2020
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 the patient underwent an acl reconstruction procedure about 2-3 years ago where a bio-transfix, ar-1351lb, was implanted.The patient has since had a piece of the transfix removed by another surgeon.No further details.
Additional Manufacturer Narrative
This is a follow-up submission to correct the initial submission.The initial submission is a duplicate of a previously submitted case reported under medwatch report number 1220246-2019-00900.

• Brand Name: BIO-TRANSFIX
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9938575
• Report Number: 1220246-2020-01791
• Device Sequence Number: 2078145
• Product Code: MAI
• UDI-Device Identifier: 00888867013742
• UDI-Public: 00888867013742
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 02/28/2017
• Device Model Number: BIO-TRANSFIX
• Device Catalogue Number: AR-1351LB
• Device Lot Number: 1216414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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