SIGMA 96-1673Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10603295239789), received between Jul 19, 2017 and Aug 13, 2024 — classified as 2 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE WRENCH GOT STUCK ON THE ADAPTER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19971240 ↗
• MalfunctionMay 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIGMA FEMORAL ADAPTER TIGHTENER GOT STUCK ON THE ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 19247391 ↗
• MalfunctionMar 21, 2023Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. SOME DEVELOPMENTS, SINCE WE SPOKE: UPON CLOSER EXAMINATION, IT WAS APPARENT, THAT THE PROBLEM WITH THE WRENCH WAS NOT, DUE TO ANY DEFECT IN THE INSTRUMENT OR IMPLANT INVOLVED, BUT SIMPLY A FAILURE ON THE PART OF THE SURGEON TO ENGAGE THE WRENCH CORRECTLY WITH THE IMPLANT. THUS, WITH THE APPROPRIATE USE OF A SPANNER, THE STEM ADAPTER WAS FREED FROM THE TORQUE WRENCH, WITH NO DAMAGE DONE. THE TORQUE WRENCH HAS BEEN RETURNED TO THE INSTRUMENT TRAY, FROM WHICH IT CAME. AND A NEW STEM ADAPTER IMPLANT HAS BEEN ORDERED BY THE HOSPITAL. THE PART IT REPLACES HAS BEEN DISCARDED. I HAVE DELIVERED EXTRA TRAINING TO THE STAFF TO REDUCE THE RISK OF A REPEAT OF THIS EVENT. EXPLAINING, THAT THE STEM ADAPTER MUST BE CORRECT / FULLY ENGAGED WITH THE TORQUE WRENCH, BEFORE THE TORQUE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581422 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT INSTRUMENT BROKE DURING KNEE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566655 ↗
• MalfunctionMay 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE WAS NOT GRIPPING AS IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336732 ↗
• MalfunctionApr 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT ASSEMBLY DEVICE GOT STUCK ON IMPLANT DURING ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189470 ↗
• MalfunctionApr 8, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE OUTER BLACK PLASTIC COVER ON THE DISTAL TORQUE MOUNT WAS MISSING AND THE INNER WHITE PLASTIC WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052588 ↗
• MalfunctionMar 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER USING THE FEMORAL ADAPTER TORQUE WRENCH SCRUB TECH HAD A VERY HARD TIME GETTING IT OFF THE FEMORAL COMPONENT. SHE STRUGGLED FOR SEVERAL MINUTES TRYING TO PULL OFF AND ALSO USING A MALLET TO TAP OFF. AFTER A FEW MINUTES IT FINALLY CAME APART. INSTRUMENT NEEDS TO BE REPLACED. THE SCRUB TECH SAID SHE THOUGHT THE INSTRUMENT NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693240 ↗
• MalfunctionFeb 9, 2022Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATED THAT DURING THE VISUAL EXAMINATION, IT WAS FOUND THAT THE DEVICE WAS STRIPPED AND UNABLE TO DISASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497793 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT BROKEN OR DULL INSTRUMENTS, THEY ALL NEED TO BE REPLACED . NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478786 ↗
• MalfunctionNov 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TC3 FEMORAL ADAPTOR TORQUE WRENCH WOULD NOT TIGHTEN THE ADAPTOR TO THE FEMORAL IMPLANT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843894 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP ON END OF WRENCH WAS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813334 ↗
• MalfunctionOct 11, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT DID NOT BREAK INTO 2 OR MORE PIECES ONLY 1 PIECE AND THE EVENT DID NOT HAPPEN INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605076 ↗
• MalfunctionSep 29, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT END OF 10MM REAMER IS BURRED SO IT GETS STUCK ON MODIFIED HUDSON ADAPTER. MODIFIED HUDSON ADAPTER IS STRIPPED THEREFORE THE REAMERS WILL NOT WORK PROPERLY WHEN ATTACHED TO THE POWER. THE CONNECTING END OF THE FEM ADAPTER TORQUE WRENCH IS WORN AND WILL NOT HOLD FEM ADAPTER FIRMLY IN PLACE WHEN APPLYING TORQUE. PLEASE SEND REPLACEMENTS P1 TO TRIDENT ATTN: OR/JASON OZMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548799 ↗
• MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  QUESTIONS: 1. WAS THERE ANY ADVERSE CONSEQUENCES TO PATIENT DUE TO THE DELAY/EVENT? 2. PLEASED SPECIFY WHAT WAS WRONG WITH THE TORQUE WRENCH AS TO WHY IT GOT STUCK ONTO THE FEMORAL ADAPTOR. ANSWERS: NO ADVERSE CONSEQUENCES FOR THE PATIENT. NOT SURE WHY IT GOT STUCK ON THE ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331199 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY. THERE ARE NO PIECES BROKEN OFF FROM THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 12316390 ↗
• MalfunctionAug 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE WRENCH GOT STUCK IN THE ADAPTER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280530 ↗
• MalfunctionJun 21, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE THAT THREAD ON BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033092 ↗
• MalfunctionJun 3, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SCREW FELL OUT AND WAS LOST DURING WASHING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932540 ↗
• MalfunctionApr 26, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE RUBBER PART OF THE FEMORAL ADAPTER TORQUE WRENCH THAT GOES OVER THE ADAPTER WAS MISSING. THAT MADE IT A LITTLE DIFFICULT TO GET THE WRENCH OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727622 ↗
• MalfunctionApr 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE BOX TRIAL'S ATTACHMENT BROKE AND THE TORQUE WRENCH STRIPPED DURING NORMAL USE. NO DELAY TO SURGERY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657187 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ADAPTER BOLT TORQUE WRENCH WAS HAVING DIFFICULTY COMING OFF THE ADAPTOR ONCE TIGHTENED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585802 ↗
• MalfunctionMar 5, 2021Structural Problem; Structural Problem

  IT WAS REPORTED THAT LOCKING HANDLE DOESN¿T SIT FLUSH ON 5 DEGREE ADAPTER FOR ASSEMBLY. SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421328 ↗
• MalfunctionFeb 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING PROCEDURE THE ADAPTER TORQUE WRENCH DID NOT ENGAGE WITH THE ADAPTOR AND BOLT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372300 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP OF THE TORQUE WRENCH BROKE OFF PREVENTING THEM FROM BEING ABLE TO TIGHTEN THE ADAPTOR BOLT. ALL PIECES WERE RETRIEVED FROM THE PATIENT, HOWEVER, THE PLASTIC PIECE WAS THROWN AWAY AND WILL NOT BE BEING RETURNED. THE WRENCH PORTION WILL BE BEING RETURNED. IT WAS ALSO REPORTED THAT WHILE SIZING THE TIBIA, THE VIEW PLATE BROKE IN HALF. BOTH PIECES WERE RECOVERED FROM PT AND ARE BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984729 ↗