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

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/05/2021, it was reported by an arthrex representative via e-mail that an ar-1530bc biocomposite-tenodesis screw was used in reconstruction of the lateral collateral ligament of the hallux on (b)(6) 2021.During insertion of the screw into the proximal phalanx, the inserter was broken, and the broken piece fell off into the screw.The surgeon was unable to remove the broken piece but the screw was fixated into the patient and the case was completed.
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.

• 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: 13152743
• Report Number: 1220246-2022-04225
• Device Sequence Number: 14549286
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 12/31/2024
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 12547390
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/04/2022
• Date Device Manufactured: 01/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown