MAUDE Adverse Event Report: ARTHREX, INC. 3.7MM DRILL BIT, CANNULATED, AO, REUSE

Model Number	3.7MM DRILL BIT, CANNULATED, AO, REUSE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8925dc-ru, drill bit, batch 032115, was returned for investigation.Visual evaluation of the device noted that the tip was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can ba attributed to misuse due to prying/leveraging the device during use.The complaint allegation is confirmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a syndesmosis surgery the drill got stuck inside the tightrope.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update cmackenbach 3-jul-2025 further information was received that initial provided information was incorrect.Apparently, the guidewire for tightrope ar-8920p got stuck on the drill bit ar-8925dc-ru.It was then impossible to separate te two parts.

• Brand Name: 3.7MM DRILL BIT, CANNULATED, AO, REUSE
• Common Device Name: DRILL BIT
• 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: 22542088
• Report Number: 1220246-2025-02956
• Device Sequence Number: 8726623
• Product Code: HTW
• UDI-Device Identifier: 00888867379893
• UDI-Public: (01)00888867379893(11)210511(10)032115
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 09/10/2025

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: 3.7MM DRILL BIT, CANNULATED, AO, REUSE
• Device Catalogue Number: AR-8925DC-RU
• Device Lot Number: 032115
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown