SIGMA 96-1670Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295239765), received between Sep 14, 2017 and Jul 21, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR TO THE HUDSON HAD STRIPPED AND IT WAS REMOVED FROM USE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370668 ↗
• MalfunctionMay 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PREPARE THE FEMUR FOR A FEMORAL SLEEVE, THE ADAPTER, SHAFT AND SUBSEQUENTLY T-HANDLE WERE "SLIPPING". UPON INSPECTION AFTER THE PROCEDURE, WEAR IS NOTED ON EACH AND WILL BE SENT FOR REPLACEMENT. IT WAS ALSO REPORTED THAT A SEPARATE FORM WAS SUBMITTED FOR THE IMPLANTS. WITH A 2 MINUTES DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11761012 ↗
• MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ALL REAMERS WERE LOOSE ON THE ADAPTERS AND SPUN FREELY. ADAPTER WOULD SPIN FREELY WHEN ATTACHED TO REAMERS OR ANY OTHER ATTACHMENT. T-HANDLE WAS ALSO LOOSE. ATTACHMENT POINT SEEMS TO BE WEAK AND CAME FREE AT FIRST SIGN OF RESISTANCE. NO PIECES BROKE OFF IN PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 AS A RESULT OF DEPUY INSTRUMENTS NOT FUNCTIONING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 11057497 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING CASE REAMER AND FED ADB SHAFT WOULD NOT STAY ON HUDSON ADAPTER LOOKS LIKE END OF REAMER AND SHAFT ARE ROUNDED OUT AND ADAPTER STRIPPED. A SURGICAL DELAY OF THIRTY SECONDS.

  Patient problems: No Code Available

  MAUDE report 10542746 ↗
• MalfunctionMay 28, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE MBT REVISION T-HANDLE, SIGMA FEM ADAPTER SHAFT, AND MODIFIED HUDSON ADAPTER ARE STARTING TO SHOW SOME ROUNDING OUT OR STRIPPING OUT. THERE WAS NO DELAY IN THE CASE. ALL PIECES WILL BE RETURNED TO DISTRIBUTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094973 ↗
• MalfunctionFeb 12, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER SHAFT WOULD NOT STAY CONNECTED TO HUDSON ADAPTER OR MBT REVISION T HANDLE SHAFT THAT CONNECTS TO ADAPTER AND T HANDLE SEEMS WORN DOWN T HANDLE AND ADAPTER WHERE SHAFT OF REAMER CONNECTS TO SEEMS WORN DOWN.

  Patient problems: Not Applicable

  MAUDE report 9702076 ↗
• InjuryDec 21, 2018Naturally Worn; Naturally Worn

  THE INSTRUMENTS WERE WORN.

  Patient problems: No Code Available

  MAUDE report 8190828 ↗
• MalfunctionNov 6, 2017Dull, Blunt; Dull, Blunt

  THE SHORT REV ADP REM SHAFT INSTRUMENT WAS REPORTED FOR BEING STRIPPED.

  Patient problems: No Information

  MAUDE report 7005299 ↗
• MalfunctionSep 14, 2017Loose or Intermittent Connection; Connection Problem; Naturally Worn; Loose or Intermittent Connection; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT THE SHAFT ADAPTER IS WEAR WHERE IT CONNECTS TO THE DRILL.

  Patient problems: No Information

  MAUDE report 6866316 ↗