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	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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 (b)(6) 2023, it was reported by a sales representative via email that the anchor from an ar-8978-cp hand/wrist internalbrace implant system could not be threaded in the bone.This was discovered during a cmc internal brace procedure on (b)(6) 2023.The case was completed using another anchor.Additional information received on 9/11/2023: the case was completed using another ar-8978-cp hand/wrist internalbrace implant system; nothing broke inside the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8978-cp was received for investigation.Visual inspection identified that one of the tips of the eyelet had bent.The screw and driver do not have any issues.Functional testing noted that the driver works smoothly as required.Refer to investigation photos.The method used to prepare the bone, as well as the bone quality encountered, was not provided.Per dfu-0307-eo revision 1.G.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.6.Ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket.8.Ensure that the angle of anchor insertion is perpendicular to the bone.The most likely cause for the reported failure can be attributed to improper bone preparation, misalignment insertion of the device during insertion; prying/leveraging the device during insertion.

• 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: 17817346
• Report Number: 1220246-2023-07982
• Device Sequence Number: 20358648
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• 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,Followup
• Report Date (Section B): 08/16/2024

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 Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 15092538
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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