SPECIALIST 96-6312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295247784), received between Mar 30, 2021 and Aug 18, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249444 ↗
• MalfunctionAug 10, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INSTRUMENT IS WORN AND SCRATCHED. SURGERY TIMES AND PATIENT NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200374 ↗
• MalfunctionMay 11, 2022Break; Break

  ONE OF THE SPIKES THAT STICKS INTO THE BONE HAS SNAPPED OFF, SO NO LONGER SECURES DURING USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14361915 ↗
• MalfunctionFeb 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THESE INSTRUMENTS ARE BEING REPORTED FOR NATURAL WEAR AND TEAR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577139 ↗
• MalfunctionAug 24, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE SPIKES BROKE OFF WHEN REMOVING THE ITEM FROM THE PATIENT, NO DELAY TO SURGERY OR HARM TO PATIENT AND ALL PARTS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358063 ↗
• MalfunctionJul 21, 2021Material Deformation; Material Twisted/Bent; Naturally Worn; Material Deformation; Material Twisted/Bent; Naturally Worn

  SURGEON SPIKED TIBIAL ALIGNMENT GUIDE ¿ ONE OF THE SPIKES WAS BENT UPON IMPACTION INTO THE TIBIA ¿ ITEM IS OVER 8 YEARS OLD ¿ WEAR AND TEAR. NO IMPACT TO SURGERY. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204125 ↗
• MalfunctionMar 30, 2021Material Twisted/Bent; Material Twisted/Bent

  SP2 TIBIAL GUIDE REQUIRES REPLACEMENT, SCREWS ARE WORN OUT AND SO THE SYSTEM WON¿T WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592608 ↗