SPECIALIST P.F.C. SIGMA 96-6160Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 P.F.C. SIGMA FEMORAL INSERTER/EXTRACTOR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist femoral inserter and extractor instrument has 86 malfunction reports, with no deaths or injuries. The reports mostly describe broken bolts, loose screws, and bent or deformed parts, and most report no patient consequences. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295247050), received between Sep 11, 2017 and May 22, 2025 — classified as 86 malfunctions.
The most frequently reported specific device problem is “Break” (60 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.
Reports received per month
Most reported problems
Device problems
- Break60
- Device-Device Incompatibility15
- Unintended Movement11
- Naturally Worn4
- Crack3
- Loose or Intermittent Connection3
- Material Deformation3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Consequences Or Impact To Patient22
- Insufficient Information4
- No Code Available3
- No Information3
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THE BOLT THAT HOLDS THE BLACK PLASTIC INSERTER /EXTRACTOR COMPONENT HAS BROKEN OFF LEAVING THE THREADED PART STUCK IN THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072017 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT DURING THE SURGERY, THE DEFINITIVE FEMUR IMPACTOR WAS DAMAGED. FOR THIS NOVELTY, THERE WERE NO ISSUES ON THE PART OF THE SPECIALIST SINCE AT THE TIME THE IMPACTOR WAS DAMAGED, THE PROSTHESIS IMPLANT WAS PERFORMED IN ITS ENTIRETY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046683 ↗MalfunctionAug 8, 2024Break; Break
IT WAS REPORTED THAT THE DEFINITIVE FEMUR POSITIONER WAS FRACTURED IN SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19937522 ↗MalfunctionApr 2, 2024Break; Break
IT WAS REPORTED THAT THE BOLT ON FEMORAL INTRODUCER BROKE WHILE USING DURING SURGERY. ALL PIECES WERE COLLECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19028387 ↗MalfunctionMar 27, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE NEW FEMORAL IMPACTOR, NEVER USED. SCREW TO IMPACTION PAD CAME LOOSE, TRIED TO FIX IT BUT IT DOESN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986620 ↗MalfunctionMar 11, 2024Detachment of Device or Device Component; Material Deformation; Unintended Movement; Detachment of Device or Device Component; Material Deformation; Unintended Movement
THE FEMORAL IMPLANT POSITIONER, HAS THE SCREWS LOOSE. I WAS DISRUPTED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18873487 ↗MalfunctionJan 8, 2024Material Deformation; Material Deformation
IT WAS REPORTED WAS REPORTED THAT DEVICE WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18465423 ↗MalfunctionDec 18, 2023Break; Break
THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGES. PFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGE. SP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKEN. SIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGE. SIGMA HP UNI ANTERIOR CHISEL WERE BENT. PFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPED. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346259 ↗MalfunctionDec 18, 2023Break; Break
THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGES PFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGE SP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKEN SIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGE SIGMA HP UNI ANTERIOR CHISEL WERE BENT PFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPED THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346201 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DEVICE WILL NOT HOLD PROPERLY. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? N/A. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. DESCRIPTION: THEY HAVE COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334713 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DEVICE WILL NOT HOLD PROPERLY. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO . DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? N/A. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. DESCRIPTION: THEY HAVE COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334709 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DEVICE WILL NOT HOLD PROPERLY. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? N/A. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. DESCRIPTION: THEY HAVE COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334686 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DEVICE WILL NOT HOLD PROPERLY. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO DID THE EVENT HAPPEN DURING A PROCEDURE? NO WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO EVENT OUTCOME/HOW WAS IT MANAGED? N/A WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO DESCRIPTION: THEY HAVE COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334673 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DEVICE WILL NOT HOLD PROPERLY. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO DID THE EVENT HAPPEN DURING A PROCEDURE? NO WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO EVENT OUTCOME/HOW WAS IT MANAGED? N/A WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO DESCRIPTION: THEY HAVE COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334664 ↗MalfunctionDec 12, 2023Break; Break
IT WAS REPORTED THAT DURING PRIMARY TOTAL KNEE ARTHROPLASTY, THE FEMORAL INTRODUCER ATTACHMENT OF THE SIGMA SLAP HAMMER HAD A PIECE BREAK OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18309360 ↗MalfunctionJun 26, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO PATIENT HARM. NO IMPACT TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17199364 ↗MalfunctionMay 12, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BLOCKS THAT GRIP THE FEMORAL COMPONENT BECAME LOOSE AND WOULD NOT RE-TIGHTEN CAUSING THE INSTRUMENT TO BECOME UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16919963 ↗MalfunctionMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AT THE TIME OF OPENING THE INSTRUMENT, IT WAS IDENTIFIED THAT THE DEVICE IS DISASSEMBLED AND MISSING A SCREW FOR ITS ASSEMBLE. THE SURGERY WAS PERFORMED WITHOUT ANY COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16909947 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823528 ↗MalfunctionApr 18, 2023Break; Break
IT WAS REPORTED THAT THE TWO FEMORAL INTRODUCERS ARE DAMAGED. THE INTERFACE BETWEEN THE BLACK PLASTIC AND THE METAL HOUSING IS BROKEN AND CANNOT BE REJOINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760541 ↗MalfunctionApr 18, 2023Break; Break
IT WAS REPORTED THAT THE TWO FEMORAL INTRODUCERS ARE DAMAGED. THE INTERFACE BETWEEN THE BLACK PLASTIC AND THE METAL HOUSING IS BROKEN AND CANNOT BE REJOINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760536 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE PFC SPECIALIST 2 FEMORAL INSERTER BROKE WHILE IMPACTING FEMUR TRIAL. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16487953 ↗MalfunctionFeb 17, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE IN TO TWO PARTS ONLY. OPERATION CONTINUED, NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16395906 ↗MalfunctionFeb 7, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE IN TO TWO PARTS ONLY. OPERATION CONTINUED; NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16311343 ↗MalfunctionFeb 3, 2023Break; Break
IT WAS REPORTED THAT THE BLACK BLOCK FELL OFF OF INSERTER UPON IMPACTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16291611 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page