MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,PEEK,VENT; SCREW, FIXATION, BONE

Model Number	TENO SCRW,PEEK,VENT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2021
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 that upon inserting the ar-1547ps, 4.75 peek tenodesis screw into bone the leading threads started to crack on the screw.The surgeon apparently noticed at this point, backed out the screw and opened a new screw which went in no problem.The surgery was completed with no issues to the patient or with any other products.The bone quality was hard.The rep reported a small piece of the first thread of the screw broke off.The rep stated the surgeon did not make any mention of an unretrieved fragment.
Additional Manufacturer Narrative
Complaint confirmed, the distal end of the screw broke.The device was found to meet relevant critical specifications.The cause of the event is undetermined, however likely causes include improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: TENO SCRW,PEEK,VENT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11435906
• Report Number: 1220246-2021-02673
• Device Sequence Number: 14167422
• Product Code: HWC
• UDI-Device Identifier: 00888867018785
• UDI-Public: 00888867018785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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,Followup
• Report Date (Section B): 03/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1547PS
• Device Lot Number: 11524308
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1