MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2020
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 that during a thumb ucl reconstruction the screw could not be detached from the handle.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device from another manufacturer.The surgeon has switched to a different technique to finish the procedure.Update 14-dec-2020: further information was provided that no additional incision was necessary due to the technique change.
Additional Manufacturer Narrative
Complaint confirmed, the screws were found to be tight but came off without being damaged.The driver tips were found to meet specifications but the screws internal hex features could not be measured due to the deformation observed.The cause is undetermined.
Additional Manufacturer Narrative
Complaint confirmed, the screws were found to be tight but came off without being damaged.The driver tips were found to meet specifications but the screws internal hex features could not be measured due to the deformation observed.The cause is undetermined.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11046757
• Report Number: 1220246-2020-02424
• Device Sequence Number: 11061143
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2021

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: 04/30/2025
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10977992
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020; 12/02/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/15/2021; 06/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other