MAUDE Adverse Event Report: IN2BONES, USA COLAG; 2.7 COLAG REAMER

Model Number	P06 N0451
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned and lot number was not provided.The cause of the issue could not be determined.
Event or Problem Description
During drilling over.002 wire, the drill broke/ unravelled.The tip of the drill was lodged in the patient's bone.The drill had just started hitting bone when this occurred.

• Brand Name: COLAG
• Common Device Name: 2.7 COLAG REAMER
• Manufacturer (Section D): IN2BONES, USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES, USA; 6000 poplar aven; suite 115; memphis 38119
• Manufacturer Contact: laveeda leflore ; 6000 poplar avenue; suite 115; memphis 38119 ; 9012607931
• MDR Report Key: 15845642
• Report Number: 3011580264-2022-00007
• Device Sequence Number: 20329075
• Product Code: HTO
• UDI-Device Identifier: 00817906029871
• UDI-Public: 00817906029871
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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
• Device Model Number: P06 N0451
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: P06 N0451 - 2.7 COLAG REAMER
• Patient Age: 14 YR
• Patient Sex: Male