SIGMA 2011-03-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295436379), received between Dec 20, 2017 and Sep 16, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791013 ↗
• MalfunctionSep 10, 2026Calibration Problem

  It was reported that the torque screwdriver did not function as a torque limiter. It spun and never reached the limit. Another torque screwdriver was used. There were no negative outcomes or patient impact. The instrument was from mono instruments office set 1. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713412 ↗
• MalfunctionApr 10, 2026Material Deformation

  BROKEN SMALL HEX SCREW DRIVER. IT NO LONGER UNSCREWS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT: YES; IF YES, NUMBER OF MINUTES: 3; WAS PROCEDURE SUCCESSFULLY COMPLETED: YES; WERE FRAGMENTS GENERATED: UNKNOWN; IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION: UNKNOWN; PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844496 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523802 ↗
• MalfunctionMar 4, 2026Calibration Problem

  IT WAS REPORTED THAT DURING THIS KNEE REVISION IT WAS DISCOVERED THAT THE MODULAR SCREWDRIVER HANDLE WOULD NOT WORK IN REVERSE OR TORQUE WHEN TIGHTENING. THIS DID NOT CAUSE ANY DELAY. THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505332 ↗
• MalfunctionFeb 5, 2026Break; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE LIMITING SCREWDRIVER HANDLE FROM RECLAIM MONO HIP REVISION SET IS BROKEN AND DOES NOT TIGHTEN/UNTIGHTEN PROPERLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268563 ↗
• MalfunctionFeb 3, 2026Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RECLAIM MONOBLOCK INSTRUMENTS WERE USED TO SUCCESSFULLY TRIAL AND IMPLANT INTO THE PATIENT. UPON THE RETURN OF THE INSTRUMENTS TO THE OFFICE IT WAS NOTICED THAT THE SCREWDRIVER HANDLE AND TIP WERE STUCK TOGETHER AS ONE PIECE. THIS DIDN¿¿T CAUSE ANY COMPLICATIONS FOR THE PROCEDURE, THE PRODUCTS DO HOWEVER NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248762 ↗
• MalfunctionDec 10, 2025Calibration Problem; Unintended Movement; Calibration Problem; Unintended Movement

  IT WAS REPORTED THAT THE TORQUE LIMITING SCREWDRIVER WOULD NOT TORQUE DOWN BUT WOULD SPIN IN BOTH DIRECTIONS PROVIDING NO TORQUING POWER. THERE WAS NO HARM TO PATIENT, NO DELAY IN CASE, AND NO PART BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769050 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING TRIALING OF THE FEMORAL STEM THE SCREWDRIVER HANDLE BROKE. THIS DID NOT IMPACT THE LENGTH OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715915 ↗
• MalfunctionDec 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLE BOND DISASSOCIATED DURING TRAY REPOSITIONING. THE DELAY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708552 ↗
• MalfunctionNov 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE SCREWDRIVER WAS SLIPPING WHEN USED IN REVERSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565494 ↗
• MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR DID NOT ADVANCE STEM ENOUGH, DID NOT REALIZE UNTIL TRIAL NECK WAS ATTACHED, USED RECLAIM MONOBLOC SCREWDRIVER AS AN IMPACTOR TO ADVANCE STEM IN A PINCH. CAUSED SCREWDRIVER TIP AND HANDLE TO BECOME STUCK TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533579 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW DRIVER HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526654 ↗
• MalfunctionNov 10, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SCREWDRIVER RATCHET BROKE, SPINS FREELY WITHOUT LOCK BEFORE RATCHETING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512315 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER SPINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379693 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT THE TORQUE LIMITED SCREWDRIVER WAS USED, BUT ITS INTERNAL MECHANISM WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771616 ↗
• MalfunctionJul 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BLACK SCREWDRIVER HANDLE ATTACHMENT IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592508 ↗
• MalfunctionJul 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CENTER SHAFT WAS TWISTING OUT OF HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414749 ↗
• MalfunctionMay 22, 2025Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT WHILE DISASSEMBLING THE HEX ATTACHMENT FROM THE BLACK HANDLE SCREWDRIVER, THE HEX ATTACHMENT WAS COLD WELDED ONTO THE BLACK HANDLE. THERE WAS NO PATIENT HARM, NO DELAY IN THE CASE. NOTHING BROKEN FROM THE TWO INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069626 ↗
• MalfunctionMay 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE SCREW DRIVER WAS FOUND TO BE FAULTY IN THE OFFICE INSTRUMENT SET, BEFORE THE SURGERY OCCURRED. EVENT FOUND IN STERILE PROCESSING DURING FIELD INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019553 ↗
• MalfunctionApr 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BLACK SCREWDRIVER IN RECLAIM MONOBLOCK CORE CASE FAILED. THE METAL PIECE THAT FITS INTO BLACK SCREWDRIVER WAS SPINNING FREELY. NO PATIENT CONSEQUENCE. 5 MINUTE SURGICAL DELAY. THEY USED A KEYLESS CHUCK TO USE IN ITS PLACE TO HOLD THE SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902781 ↗
• MalfunctionApr 3, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE HEX SCREW DRIVER AND BIT WERE STUCK TOGETHER. IT WAS NOTICED WHEN RESETTING THE TRAY.

  Patient problems: Insufficient Information

  MAUDE report 21766489 ↗
• MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY, AND THE SCREW DRIVER AND HEX DRIVER WERE STUCK TOGETHER AND DID NOT COME APART. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21761195 ↗
• MalfunctionFeb 18, 2025Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT DURING USE OF THE SCREWDRIVER, THE SHAFT INTERNALLY BROKE AND WILL SPIN BUT NOT TIGHTEN. THERE WAS NO DELAY AND NO COMPLICATIONS. ALL PIECES RETRIEVED. THIS WILL BE RETURNING WITH THE INSTRUMENT TRAY TO THE OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402017 ↗
• MalfunctionFeb 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STAFF HAD A SCREW DRIVER HANDLE THAT WAS JUST SPINNING AND A DRIVER THAT WAS STRIPPED. THERE WAS NO DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295411 ↗