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

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/29/2021
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
On 11/05/2021 it was reported by an arthrex representative via sems that an ar-1530bc, was used in reconstruction of the radial collateral ligament of the index finger on (b)(6) 2021.During insertion of the screw into the metacarpal bone, the driver broke and the broken piece remained in the screw.The surgeon was unable to remove the broken piece, and the piece is still left in the patient's body.The case was completed using the device.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-1530bc devices were received for investigation.Visual inspection identified that one of the two ar-1530bc fragmented at the distal tip, with the drive geometry no longer present.Additionally, it was identified through the use of digital caliper id: 011 that approximately 16.04mm of the shaft appeared to have been sectioned off, as the shaft breakage sites were completely smooth in contrast to where the tip had fragmented.The second of the two returned ar-1530bc devices presented no abnormalities.The cause remains undetermined, although a probable cause can be attributed to prying/leveraging the driver tip within the screw hex during insertion.The method used to prepare the bone during the procedure, as well as the bone quality encountered, were not provided.

• 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: 12854360
• Report Number: 1220246-2021-03996
• Device Sequence Number: 12153853
• 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,Followup
• Report Date (Section B): 02/03/2022

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: 12438405
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown