MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MINI BC S-TAK 2.4X 8.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
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.The devices were reported to have been discarded.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 during a brostrom procedure, after drilling with a 1.8mm drill and upon inserting the ar-1322bcnf suture anchor mini biocomposite suturetak, the tip of the anchor broke.A second ar-1322bcnf was brought in and broke upon insertion as well.The third ar-1322bcnf used seated correctly.A second location was then drilled with a 2.0mm drill and the fourth ar-1322bcnf was inserted, and pulled out.The rep stated a bone tunnel was used to complete the procedure.Additional information received on 05/28/2019: the rep reported a total of four ar-1322bcnf from lot 10216048 broke about halfway down the anchor body during insertion.The rep confirmed all implants were removed, as they came out when the inserter was removed.The 5th anchor that was used was seated correctly.The implants were being put into the fibula.No unplanned incisions were made.The rep stated bone tunnels were used to complete the repair.The four complaint devices were discarded after the procedure, and will not be returning for evaluation.Additional information received on 05/29/2019: the rep confirmed there were a total of five implants used and four malfunctioned.The bone quality was hard.

• Brand Name: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8699403
• Report Number: 1220246-2019-01142
• Device Sequence Number: 1968583
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: 00888867010147
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091844
• 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
• Report Date (Section B): 06/14/2019

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 Expiration Date: 05/31/2020
• Device Model Number: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Device Lot Number: 10216048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/14/2019
• 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