MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM

Catalog Number	00-1015-8028
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Four of the eight screws had their heads deformed.Of the four deformed screws, the tip of one remained inside the body.The remaining four screws broke during removal.All seven screws could be removed, except for the one that remained.Situation: during extraction, 4 out of 8 screw heads were deformed or stripped at the hexagonal part during extraction, and one of the screw tip was remained in the patient's bone.The easyout instrument were used but it did not work at all because the screw was tightly fused to the bone and the hexagonal part was stripped.The remaining screw heads were broken during extraction.A hospital owned carbide drill was used to drill on to the stripped hex part to remove the screw head.Then the area around the screw shaft was reamed with a hollow reamer, and then the screws were removed.Patient injury: due to the extended operation time, there was increased bleeding, and the area around the screw was drilled with a reamer, resulting in a larger hole than usual.The delay in surgery: the operation would normally take about 30 to 40 minutes, but it took 4 hours (240 minutes), so there will be a delay of approximately 3 hours and 30 minutes (200 minutes).

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM
• Common Device Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM
• 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: 20378306
• Report Number: 3006460162-2024-00051
• Device Sequence Number: 17116034
• Product Code: HWC
• UDI-Device Identifier: 00841132144756
• UDI-Public: 00841132144756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 10/04/2024

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?: Yes
• Device Catalogue Number: 00-1015-8028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/04/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 15 YR
• Patient Sex: Male