MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICRO BIO-COMP S-TAK 2.4X 8.5; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MICRO BIO-COMP S-TAK 2.4X 8.5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
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 is expected but has not yet returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that there was a metal break at the tip.It was not possible to remove the broken fragment.It will remain inside the bone.The device was used to complete the surgery successfully.Additional information obtained: performed surgery was an broström ankle joint.
Additional Manufacturer Narrative
Complaint confirmed.The evaluation revealed the forked tip had broken.The device met all material specifications as received.There was no damage or anomaly observed that would have contributed to the reported issue.The most likely cause(s) of this type of event include not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.

• Brand Name: SUTR ANCH MICRO BIO-COMP S-TAK 2.4X 8.5
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7693329
• Report Number: 1220246-2018-00553
• Device Sequence Number: 13785367
• Product Code: MAI
• UDI-Device Identifier: 00888867088573
• UDI-Public: 00888867088573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 01/31/2020
• Device Model Number: SUTR ANCH MICRO BIO-COMP S-TAK 2.4X 8.5
• Device Catalogue Number: AR-1322BCNF-1
• Device Lot Number: 10193608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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