SPECIALIST 96-6311Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295247777), received between Sep 25, 2018 and May 12, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ROD IS STRIPPED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005542 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT KNOB AND SPRING WERE BROKEN OFF OF THE ROD. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534921 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. THE KNOB ON LOCKING MECHANISM SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076033 ↗
• MalfunctionFeb 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. DID THE EVENT HAPPEN DURING A PROCEDURE? HAPPENED AT THE END OF THE PROCEDURE WHEN TRYING TO PUT THE KIT AWAY FOR DECON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756668 ↗
• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT THE IMPACTOR BROKE DURING SURGERY. IT DOES NOT CAUSE AFFECTATION IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542585 ↗
• MalfunctionNov 9, 2023Break; Mechanical Jam; Break; Mechanical Jam

  THEY WERE NOT USED DURING SURGERY AND WHERE NOTICED AS BROKEN WHEN THE SETS WERE OPENED. NO PATIENT HARM. NO FRAGMENT RETENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099846 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT DEVICE IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 17656210 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556829 ↗
• MalfunctionJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PRODUCT HAS NO PROXIMAL RETAINING PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107913 ↗
• MalfunctionFeb 16, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE PATELLA TRIALS HAD SCORE MARKS ON THEM AS THEY ARE ALL VERY OLD AND USED. THE PROX TIB UPRODS GRUB SCREW ON THE BLACK LEVER KEEPS FALLING OUT AND DOESN¿T HOLD ONTO THE CUTTING BLOCK TIGHT ANYMORE DUE TO IT BEING VERY OLD AND USED/WORN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388898 ↗
• MalfunctionNov 17, 2022Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED: A. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO DELAY. B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO C. DID ALL REPORTED PRODUCTS BREAK INTO TWO? IF YES, WE'RE ALL PIECES RETRIEVED FROM THE PATIENT? NO ¿ JAMMED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816602 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO PIECES ARE GLUED, THE 3 DEGREE GUIDE CUTTING BLOCK IS STUCK TO THE PROXIMAL EXTRAMEDULLARY ALIGNMENT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729704 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THE LOCKING SCREW OF THE PROXIMAL EXTRAMEDULLARY ALIGNMENT GUIDE BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587391 ↗
• MalfunctionMay 23, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON OPENING THE INSTRUMENT, THE LOCKING MECHANISM OF THE PROXIMAL EXTRA MEDULLARY TIBIAL ALIGNMENT GUIDE IS BROKEN AND DOES NOT ALLOW THE CUTTING BLOCK TO BE SECURED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470839 ↗
• MalfunctionJan 4, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE GUIDE LEVER DOES NOT PROPERLY LOCK THE TIBIA CUTTING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151819 ↗
• MalfunctionOct 19, 2021Break; Device-Device Incompatibility; Unintended Movement; Break; Device-Device Incompatibility; Unintended Movement

  INTRAOPERATIVELY, A DAMAGED PART IS FOUND, WHICH IS CONSIDERED CRITICAL FOR THE CORRECT ONE OF THE EXTRAMEDULLARY GUIDE. THE VIBRATORY MOVEMENT PRODUCED BY THE SAW LOOSENS THE SCREW THAT IS THE SECURITY OR ADJUSTMENT POINT BETWEEN THE GUIDE AND THE DEVICE AND THE CONTROLLED CUT IS LOST. THE TIBIAL GUIDE THAT FITS THIS DEVICE REMAINS WITH SMALL MOVEMENTS WHICH IT SHOULD NOT HAVE EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662684 ↗
• MalfunctionOct 15, 2021Mechanical Jam; Illegible Information; Mechanical Jam; Illegible Information

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOT NUMBER OF THE ALIGNMENT DEVICE SEEMED FADE ON THE INSTRUMENT DUE TO USAGE. SURGERY TIME WAS EXTENDED TO APPROXIMATELY 5 MINUTES WHILE LOOKING FOR ANOTHER TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641446 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT THIS PIECE IS BROKEN, IT DID NOT AFFECT THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489386 ↗
• MalfunctionAug 9, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INSTRUMENT HAS A BROKEN SCREW ON THE LOCKING MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294548 ↗
• MalfunctionJul 21, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE KNURLED NUT HAS BEEN BENT ON THE PROXIMAL TIBIAL ALIGNMENT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204299 ↗
• MalfunctionApr 6, 2021Material Integrity Problem; Material Integrity Problem

  THE PROCEDURE WAS CARRIED OUT WITHOUT COMPLICATIONS, BUT AFTER WASHING THE INSTRUMENTS, THE PIECE WAS DAMAGED, PHOTOS OF THE PIECE ARE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618773 ↗
• MalfunctionFeb 18, 2019Break; Break

  UPON ENTERING THE SURGERY, IT IS EVIDENT THAT THE EXTRAMEDULLARY GUIDE OF TIBIA WAS SPLIT PIECE AND TIGHTEN THE CUTTING GUIDE N3. THE EQUIPMENT WAS DELIVERED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DISMANTLE, BUT WHEN THE SAFETY WAS BROKEN, IT WAS IMPOSSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347340 ↗
• MalfunctionSep 25, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURGEON WAS CUTTING THE TIBIA WHEN HE REALIZED THERE WAS A KNOB MISSING FROM THE ALIGNMENT ROD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908461 ↗