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	04/16/2021
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 the device broke during a flexor digitorum longus tendon transfer surgery.After inserting the screw the driver was removed and the screw just came out in bits, although the bone was assessed as soft and nothing impacted on the screw during insertion.All fragments were removed from the patient.According to the surgeon there was no harm for patient, operator or third party.The surgery was finished successfully with a different device with the part number ar-1555bc.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761347
• Report Number: 1220246-2021-03000
• Device Sequence Number: 4015750
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: 00888867018778
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/03/2021

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 Expiration Date: 04/30/2024
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 10977782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1