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	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.-one unpackaged ar-1530bc bio-composite anchor was received for investigation.Visual inspection identified that the distal-most threads of the bio-composite anchor had been stripped.Additionally, breakage was noted proximal to the hex.The method used to prepare the bone during the procedure was not provided.Probable causes are attributed to inadequate bone preparation, off-axis insertion, and/or prying/leveraging the device during insertion.
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via email that an ar-1530bc biocomposite-tenodesis screw anchor pulled out from implantation site.Surgeon prepared a 3mm bone socket and when anchor was inserted, it slipped and could not be fixed.A new product was opened and case was completed without further issues.This was discovered during a thumb cm arthroplasty procedure on (b)(6) 2022.Additional information received on 3/28/2022: per arthrex employee, the anchor did not seat and could not be used to complete the case, another one was opened to finish case.During returned device evaluation, a reportable malfunction was discovered.

• 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: 14828523
• Report Number: 1220246-2022-05129
• Device Sequence Number: 11965278
• 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): 06/27/2022

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: 08/31/2025
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 14153479
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown