MAUDE Adverse Event Report: ARTHREX, INC. GDWIRE,T-ROPE SYNDESMOSIS REPR KIT; MANUAL INSTR, GENERAL SURGICAL

Model Number	GDWIRE,T-ROPE SYNDESMOSIS REPR KIT
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
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8920p, guidewire for tightrope¿, batch unk, was returned for investigation.Visual evaluation of the device noted that the device was stuck inside an ar-8925dc-ru, batch 032115.Functional testing was not performed due to the damage to the devices.The most likely cause for the reported failure can be attributed to misuse due to prying/leveraging the device during use.The complaint allegation is confirmed.

• Brand Name: GDWIRE,T-ROPE SYNDESMOSIS REPR KIT
• 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: jared engle ; 8009337001
• MDR Report Key: 22542164
• Report Number: 1220246-2025-02955
• Device Sequence Number: 12512663
• Product Code: MDM
• UDI-Device Identifier: 00888867049024
• UDI-Public: 00888867049024
• 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): 09/15/2025

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: GDWIRE,T-ROPE SYNDESMOSIS REPR KIT
• Device Catalogue Number: AR-8920P
• 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: 09/03/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown