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

Model Number	BIO-TRANSFIX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
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.Device disposition is unknown.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 a transfix acl procedure on (b)(6) 2015 where a bio-transfix, ar-1351lb, was implanted.The surgeon notified the rep on (b)(6) 2019 that the bio-transfix, ar-1351lb, may have broken and that the patient needed a revision surgery which has taken place and was performed by a different surgeon.Exact date of revision surgery is unknown and therefore the date of notification to the rep will be used as the revision date for this report.
Additional Manufacturer Narrative
This follow-up submission is to update new event details: additional information provided 4/23/2020: the patient began to experience locking of the knee 2 years post-op.The tip of the transfix post was removed from the patient's femur during the revision procedure (date has not been provided).No further action was needed to the surgeon's knowledge.He did not replace the implant.

• Brand Name: BIO-TRANSFIX
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344475
• Report Number: 1220246-2019-00900
• Device Sequence Number: 2307815
• 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
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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 Model Number: BIO-TRANSFIX
• Device Catalogue Number: AR-1351LB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/23/2020
• 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