MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during talus surgery when the screw was placed on a dense bone at the talus, it began to crumble.It was necessary to use another screw with a lager diameter.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device ar-1555bc.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the screw broke during use.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12506039
• Report Number: 1220246-2021-03662
• Device Sequence Number: 19891421
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: 00888867018778
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 144822454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown