MAUDE Adverse Event Report: ARTHREX, INC. 4.5X14MM CORKSCREW FT, DISPS; MANUAL INSTR, GENERAL SURGICAL

Model Number	4.5X14MM CORKSCREW FT, DISPS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
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 9/8/2023, it was reported by a sales representative via (b)(4) that an ar-8927dsc 4.5x14mm corkscrew ft had an issue.The blue drill guide was placed onto the bone, and the drill was inserted on forward power to begin drilling the tunnel.As the drill went down the guide, it progressed about 8mm before the drill hub started to get caught on the guide.At this point, the drill was stuck spinning in the guide, causing metal shavings to disperse.After aborting the attempt to drill, the drill was stuck in the guide and could not be used.A new disposable kit was opened and worked great.It wasn¿t until after the new drill was used that they were able to free the original drill out of the drill guide.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On 9/14/2023, the sales representative provided the following information via email: this occurred during a peroneal tendon repair procedure.Shavings were dispersed inside the patient but retrieved.Nothing broke off inside the patient, only shavings.All shavings were retrieved.There was no adverse effect, only a short delay while a new kit was opened.The procedure was completed successfully.Additional information has been requested.On 9/26/2023, the sales representative provided the following information via email: there was a case delay of under 15 minutes reported.
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 for the reported failure can be attributed to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: 4.5X14MM CORKSCREW FT, DISPS
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 17890292
• Report Number: 1220246-2023-08097
• Device Sequence Number: 6938936
• Product Code: MDM
• UDI-Device Identifier: 00888867131538
• UDI-Public: 00888867131538
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 4.5X14MM CORKSCREW FT, DISPS
• Device Catalogue Number: AR-8927DSC
• Device Lot Number: 15038056
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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