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

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is not confirmed.Three unpackaged, and two packaged ar-1547cds biocomposite-tenodesis serial/batch number 13807670 were received for investigation.Visual evaluation of three returned opened devices with a magnifier didn't find sharp edges on the hex driver tip.One of the arrived packaged devices was opened an observed under the magnifier and didn't find any sharp edge on this one either.
Event or Problem Description
It was reported that during a tendon refixation surgery the driver of the device cut off the associated loop at the front with the metal edge (fiberwire loop).This happened twice in one surgery.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update, khe, 13-jan-2023 5 x ar-1547cds were received (3 x used, 2 x original packed).

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19381087
• Report Number: 1220246-2024-03716
• Device Sequence Number: 3727427
• Product Code: HWC
• UDI-Device Identifier: 00888867233959
• UDI-Public: 00888867233959
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 06/30/2023
• Device Model Number: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• Device Catalogue Number: AR-1547CDS
• Device Lot Number: 13807670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown