MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM; SCREW, FIXATION, BONE

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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 12/27/2022, it was reported by a sales representative via email that an ar-1547cds biocomposite-tenodesis screw broke a couple of threads during implantation.This was discovered during an allograft syndesmosis reconstruction on (b)(6) 2022.The broken fragment was retrieved and the case was completed by using a new ar-1547cd.Additional information provided: the procedure was an allograft syndesmosis reconstruction.A 5mm hole was reamed across the fibula and tibia in two spots.The 4.5 mm icon graft was shuttled through both tunnels with tenoscrews to be placed in tibia to fixate it.Bone was rated as good.The first 1ar-1547cds used went in successfully and the second ar-1547cds broke a couple threads in.

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• 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: 16173286
• Report Number: 1220246-2023-06106
• Device Sequence Number: 4152091
• Product Code: HWC
• UDI-Device Identifier: 00888867233959
• UDI-Public: 00888867233959
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/16/2023

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: 07/31/2024
• Device Model Number: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• Device Catalogue Number: AR-1547CDS
• Device Lot Number: 14995949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/16/2023
• Date Device Manufactured: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown