MAUDE Adverse Event Report: IN2BONES USA COLAG; COLAG SINGLE-USE STERILE INSTRUMENT KIT

Model Number	P06 S0004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a cannulated drill broke off while drilling.The surgeon was unable to fully remove the drill and the patient's medial malleoulus broke while attempting to remove the drill.The surgery was able to be completed successfully with k-wires.The dhr review confirmed that the single-use, sterile drill was manufactured to specifications.

• Brand Name: COLAG
• Common Device Name: COLAG SINGLE-USE STERILE INSTRUMENT KIT
• Manufacturer (Section D): IN2BONES USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer Contact: robert buchanan ; 6000 poplar avenue; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 21644151
• Report Number: 3011580264-2025-00002
• Device Sequence Number: 20724052
• Product Code: LXH
• UDI-Device Identifier: 00810021866086
• UDI-Public: (01)00810021866086(17)280828(10)1572768
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: P06 S0004
• Device Catalogue Number: P06 S0004
• Device Lot Number: 1572768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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 Age: 39 YR
• Patient Sex: Female