MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 32MM

Catalog Number	00-1015-8032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient admitted to the operating room (or) for an ortho hardware removal.Healthcare provider attempted to remove screws with appropriately sized screwdriver.All four screw heads broke in the same way - about 8mm of shaft attached to the heads.The fragments were removed using trephines.

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 32MM
• Common Device Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 32MM
• 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: 20561774
• Report Number: 3006460162-2024-00067
• Device Sequence Number: 11535277
• Product Code: HWC
• UDI-Device Identifier: 00841132144763
• UDI-Public: 00841132144763
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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 Catalogue Number: 00-1015-8032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• 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
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White