MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scapholunate recon surgery it was found that the hand and wrist disposable kit did not contain a drill guide when it was opened.An arthrex representative was at the surgery and supported the surgeon.The customer the used the clear funnel to hold the key wires.The surgeon measured out the depth of the anchor and cut the tube with a scalpel to finish the surgery successfully.There was no harm for patient, operator or third party reported.Update dw 13-nov-2023.Further information were provided that the procedure could be carried out exactly like it should and that no additional surgery was necessary.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to a user error mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: emily shafer ; 8009337001
• MDR Report Key: 18287521
• Report Number: 1220246-2023-09283
• Device Sequence Number: 12309516
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150648
• 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): 03/11/2025

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 Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 15120517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2023
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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