MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
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 during a hip scope procedure the anchor broke during insertion.The doctor went to the hard bone drill to open the tunnel but the same issue with four other implants.All was retrieved from the patient.He switched to a push lock and everything worked fine and case was completed successfully.The patient is fine to date.

• Brand Name: 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11724456
• Report Number: 1220246-2021-02939
• Device Sequence Number: 19603255
• Product Code: MAI
• UDI-Device Identifier: 00888867097193
• UDI-Public: 00888867097193
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
• Device Catalogue Number: AR-1938BCH
• Device Lot Number: 10349875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1