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

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2019
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 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 a peek tenodesis screw, ar-1530ps, was being used in a procedure.During insertion, the tip of the driver broke off into the head of the screw and was unable to be removed.The screw and tip were left in the patient.Patient is a male, (b)(6).Additional information provided 12/9/2019: procedure being performed was a scapholunate.No additional incision was needed.No photos available.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the device broke off at the shoulder.The most likely causes include improper bone prep, misaligned insertion, prying/leveraging the device.

• 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: 9519347
• Report Number: 1220246-2019-01526
• Device Sequence Number: 2851559
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 12/31/2023
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10270852
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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