MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IB KIT, PEEK, NON-COLLAGEN COATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 an ankle instability surgery thetip of the 2.7mm cannulated drill broke off.All broken parts were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with another drill from the kit.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the part returned from the kit, the drill bit, 2.7 mm.Had the distal end of the flutes broken off.Only component c8867-05, drill bit, 2.7 mm was returned from the kit ar-1778p-cp for investigation.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to misaligned insertion, excessive force used, and/or the device coming in contact with another device during use.

• Brand Name: IB KIT, PEEK, NON-COLLAGEN COATED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21968763
• Report Number: 1220246-2025-01913
• Device Sequence Number: 8414861
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: (01)00888867318120(11)241015(17)290930(10)15332386
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Device Lot Number: 15332386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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