Orthohelix Surgical Designs Inc: The tips of the drivers are breaking while being used to drive the screws into patients.

Agency Publication Date: October 9, 2012

Affected Products

Product: OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

HSC-056-32-1067051

Product: OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

HSC-056-38-1067061

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 54725

Status: Resolved

Manufacturer: Orthohelix Surgical Designs Inc

Manufactured In: United States

Units Affected: 2 products (47 Pieces; 120 Pieces)

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Sources: FDA iRES · Raw API Response

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Affected Products

HSC-056-32-1067051

HSC-056-38-1067061