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

Model Number TENODESIS SCREW, PEEK

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 11/26/2020

Event Type  malfunction  

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 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.

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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11046757
• MDR Text Key: 222682567
• Report Number: 1220246-2020-02424
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (y/n): N
• PMA/PMN Number: K051726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10977992
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other