SIGMA 9505-02-055Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT KEEL PUNCH IMPACTOR · Class 1
Quick summary
This DePuy Sigma keel punch impactor has 168 reports, with no deaths and no injuries. Many reports describe the handle slipping off the keel punch or loosening, worn rubber O-rings that shed debris, and parts that did not fit together or cracked. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 168
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10603295227717), received between Jul 19, 2017 and Feb 21, 2025 — classified as 168 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (70 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility70
- Break45
- Naturally Worn24
- Material Twisted/Bent12
- Loose or Intermittent Connection10
- Unintended Movement7
- Component Missing6
- Connection Problem5
Patient problems
- No Consequences Or Impact To Patient72
- No Clinical Signs, Symptoms or Conditions61
- Not Applicable16
- No Code Available11
- Insufficient Information9
- No Information8
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE POSITIONING INSTRUMENT'S RUBBER O-RINGS AT THE SHIM CONNECTIONS ARE WORN AND CREATES LOOSE RUBBER DEBRIS DURING USE. THE IMPACTOR SLIPS OFF THE KEEL-PUNCHES DURING USE EVEN WHEN SET SCREWS ARE TIGHTENED. THE TRIAL HAS A CRACK IN THE CONNECTION TO TRIAL TRAYS, NO PLASTIC PART HAVE FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432889 ↗MalfunctionOct 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SIDE BUTTON AND SCREW IS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 20504812 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED INTRAOPERATIVELY ON OCTOBER 3, 2024 THE HANDLES ¿SLIPS OFF¿ AT KEEL PUCH CONNECTION AND IT LOOSES THE GRIP ON THE KEEL PUNCH. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED WITH THE SAME LIKE PRODUCT.
Patient problems: Insufficient Information
MAUDE report 20438594 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED INTRAOPERATIVELY ON (B)(6) 2024 THE HANDLES ¿SLIPS OFF¿ AT KEEL PUCH CONNECTION AND IT LOOSES THE GRIP ON THE KEEL PUNCH. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED WITH THE SAME LIKE PRODUCT.
Patient problems: Insufficient Information
MAUDE report 20438548 ↗MalfunctionNov 21, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18181525 ↗MalfunctionNov 9, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT WHILE IMPACTING THE KEEL PUNCH, THE BUTTON TO SECURE THE KEEL PUNCH WAS VERY LOOSE. NOTHING BROKE OFF FROM THE INSTRUMENT. KEEL PUNCH WOULD NOT ATTACH PROPERLY DUE TO LOOSE BUTTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100052 ↗MalfunctionOct 30, 2023Device-Device Incompatibility; Naturally Worn; Unintended Movement; Device-Device Incompatibility; Naturally Worn; Unintended Movement
IT WAS REPORTED THAT THE KEEL PUNCH OF THE TÍBIA IS DAMAGED. THE PUNCHS' HANDLE OF THE FINAL TIBIA PREPARATION IS DAMAGED; IT HAS TOO MUCH SLACK AND DOES NOT PROPERLY SECURE THE PUNCHS. IT ALSO HAS THE SCREW FASTENING LOOSE. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18030415 ↗MalfunctionOct 9, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS THE REPORTED THAT THE TIBIAL PUNCH HANDLE TIP IS WORN AND DISCONNECTS FROM TIBIAL PUNCH UPON EXTRACTION.
Patient problems: Insufficient Information
MAUDE report 17897650 ↗MalfunctionOct 5, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE TIBIAL PUNCH HANDLE HAS WORN TIP AND TIBIAL PUNCH DISENGAGES UPON EXTRACTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17875479 ↗MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT WILL NOT CONNECT TO KEEL PUNCH. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17833972 ↗MalfunctionAug 23, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED. A. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? IF YES, WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? YES, NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608202 ↗MalfunctionMay 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS NOT ATTACHING TO PUNCH PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894388 ↗MalfunctionApr 27, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL KEEL PUNCH HANDLE IS LOSING ITS GRIP. PUNCH DOES NOT STAY ON HANDLE VERY WELL. DIDN'T NOT EFFECT SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823424 ↗MalfunctionApr 20, 2023Break; Break
IT WAS REPORTED THAT THE SCREW THAT HOLDS THE RELEASE BUTTON CAME OUT AND WAS LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777245 ↗MalfunctionApr 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT NO LONGER CONNECTS WELL TO THE KEEP PUNCH AND DISCONNECTS WHEN TRYING TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16689065 ↗MalfunctionMar 14, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BUTTON CAME OFF. WILL NOT CATCH TO TAKE KEEL PUNCH OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539713 ↗MalfunctionDec 27, 2022Break; Break
IT WAS REPORTED THE IMPACTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16055260 ↗MalfunctionDec 5, 2022Break; Break
IT WAS REPORTED THAT THE HANDLE WAS BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15916638 ↗MalfunctionNov 21, 2022Break; Break
IT WAS REPORTED THAT THE PUNCH HANDLE BUTTON FELL OUT OF HANDLE. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15834153 ↗MalfunctionOct 25, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT IS FAULTY DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668524 ↗MalfunctionOct 20, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
HAS BEEN REPORTED AS NOT WORKING PROPERLY DUE TO FAIR WEAR AND TEAR. THERE WAS A DELAY IN SURGERY OF APPROX 5 MINS. THE MOVING CATCH ON THE INSTRUMENT IS WORN AND NO LONGER ENGAGES PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638743 ↗MalfunctionAug 9, 2022Break; Break
IMPACTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192445 ↗MalfunctionAug 9, 2022Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE THREAD ON SCREWS SHEARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191028 ↗MalfunctionJun 16, 2022Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE FBT KEEL PUNCH IMPACTOR, A SCREW CAME LOOSE FROM THE BUTTON YOU PRESS ON THE HANDLE. THE LOOSE SCREW/BUTTON FELL OFF THE HANDLE. ALL ITEMS WERE RETRIEVED FROM THE STERILE FIELD. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14718090 ↗MalfunctionJun 13, 2022Contamination /Decontamination Problem; Material Integrity Problem; Mechanical Jam; Contamination /Decontamination Problem; Material Integrity Problem; Mechanical Jam
IT WAS REPORTED THAT THE SIGMA HP HANDLE GOT INTO ONE OF THE HOLES ON THE DEVICE AND PENETRATED INTO THE INTERNAL CANAL, WHICH BLOCKED THE MOVING PART OF THE HANDLE MECHANISM. ALL ATTEMPTS BY DOCTORS TO RESTORE THE FIXATION MECHANISM TO COMPLETE THE SURGERY WERE UNSUCCESSFUL. THE PATIENT WAS NOT HURT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676333 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.