MalfunctionHTW

TECOMET

Received Mar 23, 2021 · Event occurred Feb 12, 2021

Report 11552963 · MDR key 11552963

Device

Generic name

Bit, Drill

Manufacturer

Tecomet Inc.

Model number

HD207T10

Catalog number

HD207T10

Product problems

Break
Entrapment of Device
Naturally Worn

Patient

21535 DA

Device Embedded In Tissue or Plaque
Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

THE TIP OF A TECOMET REUSABLE SURGICAL SCREWDRIVER BROKE INTO SEVERAL PIECES DURING THE REMOVAL OF ORTHOPEDIC SPINAL HARDWARE. SEVERAL PIECES WERE SEQUESTERED. HEALTH CARE PROVIDERS BELIEVE THAT THESE SCREWDRIVER TIPS BECOME WORN DOWN OR WEAKENED WITH MULTIPLE USES.