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

Model Number P06 N0451

Device Problem Fracture (1260)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Product was not returned and lot number was not provided.The cause of the issue could not be determined.

Event 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
• Type of Device: 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
• MDR Text Key: 307626457
• Report Number: 3011580264-2022-00007
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00817906029871
• UDI-Public: 00817906029871
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P06 N0451 - 2.7 COLAG REAMER
• Patient Age: 14 YR
• Patient Sex: Male