MAUDE Adverse Event Report: ARTHREX, INC. G-WIRE W/TRCR TIP, 2.4MM X 9.25"; ORTHOPEDIC MANUAL SURG INSTR

Model Number	G-WIRE W/TRCR TIP, 2.4MM X 9.25"
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a subtalar arthrodesis surgery the customer experienced issues with the drill guide and the k-wire.The ar-8770-02-ru cannulated drill passes over the ar-8770k k-wire when tested, before starting the procedure.During the procedure, when the proximal cortex is drilled over the guide wire, the devices are no longer compatible.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
***update dw 11-oct-2024: further information was provided that in this specific case an ar-8770k was used and the drill got stuck and pushed the wire further.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.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 can be attributed misuse due to misaligned insertion; or prying/leveraging the device during insertion.Per dfu-0023-eo revision 4: 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.

• Brand Name: G-WIRE W/TRCR TIP, 2.4MM X 9.25"
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20439400
• Report Number: 1220246-2024-08118
• Device Sequence Number: 7995124
• Product Code: LXH
• UDI-Device Identifier: 00888867263659
• UDI-Public: 00888867263659
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 02/06/2025

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: G-WIRE W/TRCR TIP, 2.4MM X 9.25"
• Device Catalogue Number: AR-8770K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: Not provided; 01/14/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/28/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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