MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ADOLESCENT NAIL; 9MM X 340MM ADOLESCENT NAIL, LEFT

Catalog Number	00-1503-0934
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
9x340mm pnp nail was implanted, locked distally and the surgeon de-rotated the distal fragment below the osteotomy.The resident attempted to drill the greater/lesser proximal locking hole but was unable to get alignment.After several tries, the decision was to remove the nail to examine and it was discovered that at the connection of the targeting arm and nail where the attachment bolt connect, the nail had splayed from fatigue/stress from de-rotating and this caused the inability to line up the targeting arm with the proximal locking options.

• Brand Name: ADOLESCENT NAIL
• Common Device Name: 9MM X 340MM ADOLESCENT NAIL, LEFT
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 21621879
• Report Number: 3006460162-2025-00017
• Device Sequence Number: 8515775
• Product Code: HSB
• UDI-Device Identifier: 00841132146736
• UDI-Public: 00841132146736
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 00-1503-0934
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (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 Age: 12 YR
• Patient Sex: Male