MAUDE Adverse Event Report: IN2BONES USA IBS-B; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	G01 N0061
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the surgeon that the device, g01 n0061 countersink for screwsdia.3.3mm, non-sterile, was used after drilling when it was reported that the countersink fractured inside the patient.The surgeon made several attempts to remove the countersink fragments from the patient without success.The fragments remain inside the patient without further complications.

• Brand Name: IBS-B
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): IN2BONES USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer Contact: darby eime ; 6000 poplar ave; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 21984681
• Report Number: 3011580264-2025-00005
• Device Sequence Number: 17221368
• Product Code: LXH
• UDI-Device Identifier: 00810021867748
• UDI-Public: (01)00810021867748
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: G01 N0061
• Device Catalogue Number: G01 N0061
• Device Lot Number: (10)22361021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown