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	09/04/2020
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
An arthrex employee has reported that during a hallux varus surgery the tip of the inserter broke off in the screw head.The surgeon was not able to retrieve the screw and the tip of the inserter out of the patient.The surgeon had to use an additional swivelock to finish the surgery successfully.

• 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: 10546704
• Report Number: 1220246-2020-02177
• Device Sequence Number: 14211355
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 11/30/2024
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10527602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1