SPECIALIST 96-6310Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295247760), received between Dec 20, 2017 and May 13, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED. THE EVENT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010995 ↗
• MalfunctionApr 5, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ONE OF THE THREADS HAS WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683879 ↗
• MalfunctionJan 26, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE UPROD SCREW ON ANKLE CLAMP IS CROSS-THREADED. ANKLE CLAMP MEDIALIZER ALSO WON¿T MOVE. BOTH LINER TRIALS ALSO CHIPPED UPON REMOVAL. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246234 ↗
• MalfunctionNov 17, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE IS JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816385 ↗
• MalfunctionSep 29, 2022Break; Break

  DURING THE SURGERY THE TIGHTENING PART BROKE INTO THE TIBIAL TARGETING. NO ADVERSE CONSEQUENCES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501652 ↗
• MalfunctionJun 21, 2022Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ANKLE CLAMP IS BROKEN AND WONT GRIP ON TO PATIENT'S LEG & PINS ARE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755008 ↗
• MalfunctionJun 16, 2022Naturally Worn; Naturally Worn

  THE TIBIAL BASE EXTRAMEDULLARY GUIDE ARRIVES WITH ONE OF THE ADJUSTMENT KNOBS (THE DISTAL ONE) TRANS-THREADED, MAKING IT IMPOSSIBLE TO PROPERLY FIX THE GUIDE ASSEMBLY. IT HAD TO BE HELD IN POSITION MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717507 ↗
• MalfunctionNov 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TOP SCREW IS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868811 ↗
• MalfunctionNov 23, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADING MECHANISM ON LOCKING SCREWS IS GONE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860230 ↗
• MalfunctionNov 4, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE CONSIGNED SET ARE WORN. THIS KIT HAS BEEN IN CIRCULATION FOR ALMOST 15 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752455 ↗
• MalfunctionJul 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO SCREW AND UNSCREW THE INSTRUMENT AS IT NORMALLY SHOULD. HE ASKED FOR A NEW ONE. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215128 ↗
• MalfunctionJul 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 THE SCRUB TECH TRIED PUTTING THE TIBIAL ANKLE CLAMP FROM THE SIGMA SPECIALIST 2 INSTRUMENTS PAN. THE CLAMP WOULD NOT FIT INTO THE CUP ROD. THE INSTRUMENT WAS NOT USED ON THE PATIENT AND DURING THE CASE. THE INSTRUMENT DID NOT BREAK INTO PARTS AND EVERYTHING WAS COLLECTED AND SENT TO OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277875 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA ALIGN DEVICE WOULD NOT ASSEMBLE AND THE FEMORAL IMPACTOR WAS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637666 ↗
• MalfunctionMay 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ISSUE: STERILE SERVICES REPORTED THAT THE SCREW DOES NOT GO IN PROPERLY. THIS DID NOT AFFECT SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617039 ↗
• MalfunctionJan 24, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE EXTRAMEDULLARY ALIGNMENT GUIDE BECOME LOOSE DURING USE. THREADS ON THE SCREW DEEMED INSUFFICIENT FOR FUTURE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273785 ↗
• MalfunctionSep 21, 2018Break; Break

  IT WAS REPORTED THAT THE BOLT / SCREW THAT SECURES SCOPE ON TIBIAL JIG CROSS-THREADED AND BROKE OFF. JIG WAS THEN UNUSABLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898011 ↗
• MalfunctionMay 7, 2018Break; Break

  IT WAS REPORTED THAT ALL 3 INSTRUMENTS WAS BROKE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490233 ↗
• MalfunctionJan 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE OF THE SCREWS IS STRIPPED TO HOLD THE TIBIAL JIG TOGETHER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159917 ↗
• MalfunctionDec 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TIBIAL CUTTING GUIDE IS STRIPPED. IT WAS ALSO REPORTED THAT THE SCREW KNOB THAT LOCKS THE ANKLE CLAMP TO THE UP ROD IS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133568 ↗