MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP IM FEMORAL NAIL, 9 MM X 32CM, LEFT

Model Number	10-1500-093
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While explanting the pedinails the proximal segment broke off, leaving the rest of the nail in the patient, conical extractor was seated correctly, then the proximal greater to lesser screw was removed, then the distal lateral to medial screw was removed, then during back slapping the proximal segment broke off and stayed on the conical extractor while the rest of the nail was in the patient.

• Brand Name: IM FEMORAL NAIL, 9 MM X 32CM, LEFT
• Common Device Name: IM FEMORAL NAIL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 16090964
• Report Number: 3006460162-2022-00042
• Device Sequence Number: 6733539
• Product Code: HSB
• UDI-Device Identifier: 00841132177624
• UDI-Public: 00841132177624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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: 10-1500-093
• Device Catalogue Number: 01-1501-0128
• Device Lot Number: 111769
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 54 KG