MAUDE Adverse Event Report: IN2BONES, USA COLAG SINGLE-USE KIT; 1.6MM REAMER

Model Number P06 S0002

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

During a bunion procedure, a surgeon began drilling with a cannulated drill over the k-wire.During the drilling process, the tip of the drill broke after breaching the cortex.The fragment was left in the patient.The surgeon placed another k-wire to hold the fixation.

• Brand Name: COLAG SINGLE-USE KIT
• Type of Device: 1.6MM REAMER
• 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: 16020164
• MDR Text Key: 308149316
• Report Number: 3011580264-2022-00009
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P06 S0002
• Device Lot Number: 1304811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female