SIGMA LCS 9505-02-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295227861), received between May 7, 2018 and Nov 30, 2023 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionNov 30, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  ADDITIONAL INFORMATION RECEIVED STATES THAT IT IS UNSURE EXACTLY WHICH PART OF THE INSTRUMENT HAS FAILED BUT AS PER BELOW THERE IS A SMALL SCREW MISSING FROM THE HANDLE SO DOES NOT FUNCTION AS INTENDED AS DOES NOT CLOSE AROUND PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237146 ↗
• MalfunctionJul 14, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN IMPACTOR IS BROKEN. NO LONGER HOLDS ON TO PIN SECURELY. NO DELAY TO SURGERY OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014552 ↗
• MalfunctionFeb 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  PIN EXTRACTOR NO LONGER HOLDS THE PINS FOR EXTRACTING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553208 ↗
• MalfunctionFeb 1, 2022Naturally Worn; Naturally Worn

  INSTRUMENTS ARE DULL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13408388 ↗
• MalfunctionFeb 1, 2022Naturally Worn; Naturally Worn

  INSTRUMENTS ARE DULL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13408208 ↗
• MalfunctionOct 4, 2021Break; Break

  1. WAS IT BROKE INTO 2 OR MORE PIECES? NO. 2. WHICH PART OF THE HP PIN IMPACTOR/EXTRACTOR WAS BROKEN? THE PORTION WHICH IS A METAL STRIP THAT ACTS AS A SPRING WHEN GRASPING A PIN & RELEASING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571869 ↗
• MalfunctionSep 24, 2021Break; Break

  THE SPRING HANDLE NO LONGER WORKS, ALTERNATIVE USED. NO PATIENT IMPACT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528266 ↗
• MalfunctionSep 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCH. PIN PULLER INNER RESISTANCE WILL NOT STAY TOGETHER. ALL INSTRUMENT PIECES INTACT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452418 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED AS "RESISTANCE PIECE OF PIN PULLER BROKE OFF. ALL PIECES WERE RETRIEVED." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060992 ↗
• MalfunctionApr 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEPUY SYNTHES PIN EXTRACTOR IN OUR INSTRUMENT SET WOULD NOT REMOVE A PIN. THEY OPENED ANOTHER SET AND WITHOUT ANY DELAY CONTINUED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748044 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT THE PIN PULLER SPRING MECHANISM BROKE. THE INSTRUMENT BROKE IN 2 PIECES AND ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747957 ↗
• MalfunctionApr 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT IS NO LONGER ABLE TO EXTRACT THE PIN. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562224 ↗
• MalfunctionApr 8, 2019Break; Fitting Problem; Break; Fitting Problem

  THE INSTRUMENT IS NO LONGER POSSIBLE TO EXTRACT THE PIN. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8490917 ↗
• MalfunctionFeb 19, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE THE SURGEON IS IMPACTING THE TIBIA BASE PINS IN WITH THE HP PIN IMPACTOR/EXTRACTOR, THE PINS GET STUCK IN THE IMPACTOR AND CANNOT BE REMOVED. THE SIGMA SIZE 4 PS BOX TRIAL SCREW IS STRIPPED AND DOESN¿T ALLOW THE SCREW DRIVER TO TIGHTEN SCREW DOWN ON FEMUR TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349991 ↗
• MalfunctionAug 22, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ALL THREE PIN PULLERS OPENED ON A CASE AND AREN'T TIGHT ENOUGH TO GRAB THE PIN. NO SURGICAL DELAY AND ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806778 ↗
• MalfunctionAug 22, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ALL THREE PIN PULLERS OPENED ON A CASE AND AREN'T TIGHT ENOUGH TO GRAB THE PIN. NO SURGICAL DELAY AND ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806730 ↗
• MalfunctionAug 22, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ALL THREE PIN PULLERS OPENED ON A CASE AND AREN'T TIGHT ENOUGH TO GRAB THE PIN. NO SURGICAL DELAY AND ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806705 ↗
• MalfunctionJun 14, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT NO LONGER WORKS DUE TO SPRING BEING BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602727 ↗
• MalfunctionMay 7, 2018Connection Problem; Connection Problem

  THE CLIP IN THE MID OF THE INSTRUMENT DOES NOT HOLD ANY LONGER. THIS WAS SEEN IN CSSD. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR ANYBODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490242 ↗