NA 111140Recalls & reported problems
Mako Surgical Corp. · FEMORAL TRIAL SLAPHAMMER · Class 2
Quick summary
This Mako femoral trial slaphammer is an orthopedic instrument used during knee replacement to place and remove trial implants. The 24 reports mostly describe the tip or threaded screw breaking off during surgery, sometimes getting stuck inside the trial. There were no deaths and no injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00848486002732), received between Jun 8, 2018 and Aug 19, 2019 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
Device problems
- Break22
- Fracture6
- Crack2
Patient problems
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient4
- No Patient Involvement3
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2019Break; Break
TIP OF SLAP HAMMER BROKEN OFF. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8905609 ↗MalfunctionMay 7, 2019Break; Break
SLAP HAMMER THREADS WERE BROKEN INSIDE OF THE UNI TRIAL. CASE TYPE: PKA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8588217 ↗MalfunctionApr 1, 2019Break; Break
SLAP HAMMER SCREW BROKE OFF INTO THE UNI FEMUR TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8470413 ↗MalfunctionMar 27, 2019Crack; Fracture; Crack; Fracture
THE TIP OF THE SLAPHAMMER BROKE OFF AT THE SCREW THREADS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8457256 ↗MalfunctionMar 18, 2019Break; Fracture; Break; Fracture
THE TIP OF THE SLAP HAMMER BROKE OFF INSIDE THE TRIAL FEMUR.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8429996 ↗MalfunctionMar 13, 2019Break; Break
SLAP HAMMER TIP BROKE OFF IN FEMUR 7 LM TRIAL. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8418742 ↗MalfunctionMar 13, 2019Break; Break
THE SLAP HAMMER TIP FOR SIZE 7 LM PKA FEMUR INSERTION BROKE OFF IN THE TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8417981 ↗MalfunctionFeb 26, 2019Break; Break
WHILE SURGEON WAS REMOVING FEMORAL TRIAL FROM PATIENT, TIP OF SLAP HAMMER BROKE OFF AND GOT STUCK INSIDE THE TRIAL. CASE TYPE: PKA. UPDATE 08/FEBRUARY/2019: REP CONFIRMED SURGICAL DELAY OF 30 SECONDS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8371496 ↗MalfunctionJan 24, 2019Break; Break
T HANDLE BROKE OFF IN TRIAL WHEN PULLING TRIAL OUT OF PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8273763 ↗MalfunctionJan 14, 2019Break; Fracture; Break; Fracture
MULTIPLE ITEMS DAMAGED OR DID NOT WORK DURING ONE CASE. BEFORE THE SURGERY DURING BURR STATUS CHECK THE HANDPIECE PORTION FAILED AND THE FOOTPEDAL PORTION PASSED. AFTER THAT SWAPPED OUT BOTH THE END EFFECTOR AND THE ANSPACH. THE FOLLOWING EE AND ANSPACH PASSED BOTH BURR STATUS CHECKS. DURING THE CASE AFTER BURRING THE FEMUR AND HALF OF THE TIBIA THE BURR STOPPED AND SHOWED A OVERHEAT ERROR. SO I SWAPPED OUT ANSPACH SN (B)(4) FOR A THIRD LOANER SET THAT WAS AT THE HOSPITAL AND THE BURRING WAS COMPLETED WITHOUT ANY FURTHER ISSUES. DURING THE TRIALING PORTION OF THE CASE THE SLAP HAMMER FEMORAL EXTRACTOR BROKE. MINIMAL DELAY TO SURGERY UNDER 5 MINS. THIS PI IS FOR THE JOINT REPLACEMENT DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8246267 ↗MalfunctionJan 11, 2019Break; Fracture; Break; Fracture
MalfunctionJan 11, 2019Break; Break
TIP OF IMPACTOR BROKE. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8239440 ↗MalfunctionDec 6, 2018Break; Break
ITEM BROKEN. SCREW END STUCK INTO FEMORAL TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8139281 ↗MalfunctionNov 20, 2018Break; Break
ITEM BROKEN. SCREW END STUCK INTO ITEM: 170513.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8090081 ↗MalfunctionNov 7, 2018Break; Fracture; Break; Fracture
FEMORAL TRIAL HAD A PIECE OF THE FEMORAL IMPACTOR THAT BROKE OFF DURING IMPACTION. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8045970 ↗MalfunctionNov 7, 2018Break; Break
AS REPORTED: "FEMORAL IMPACTOR THREAD BROKE OFF IN TRIAL". ISSUE REPORTED DURING IMPACTION. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8045893 ↗MalfunctionOct 29, 2018Crack; Fracture; Crack; Fracture
DURING TRIAL EXTRACTION, THREADED INSERT PORTION OF THE INSERTER SNAPPED AND WAS LEFT IN TRIAL. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8016237 ↗MalfunctionOct 12, 2018Break; Break
TIP OF FEMUR EXTRACTOR BROKE OFF INSIDE SIZE 5 RIGHT MEDIAL LEFT LATERAL TRIAL IMPLANT. CASE TYPE: PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7960016 ↗MalfunctionAug 22, 2018Break; Break
TIP OF FEMUR INSERTER BROKE INSIDE FEMORAL TRIAL. PKA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7805457 ↗MalfunctionAug 14, 2018Break; Break
DURNING TRIALING, THREADED TIP OF FEMORAL INSERTER BROKE OFF IN 6LM FEMUR TRIAL. CASE TYPE: PKA. LEFT KNEE.
Patient problems: No Patient Involvement
MAUDE report 7780426 ↗MalfunctionAug 8, 2018Break; Break
THE SCREW PART OF THE SLAP HAMMER WAS BROKEN BEFORE THE CASE STARTED. CASE TYPE: PKA.
Patient problems: No Patient Involvement
MAUDE report 7764875 ↗MalfunctionJul 11, 2018Break; Break
SURGEON IMPACTED FEMORAL TRIAL INSERTER INTO FEMORAL TRIAL CAUSING THE INSERTER TO BREAK INSIDE THE TRIAL. PKA CASE DELAYED: 15 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7678568 ↗MalfunctionJun 18, 2018Break; Break
HAD TO GET THE TRIAL FEMUR OUT USING SOMETHING ELSE. UPDATE 05/25/2018: THE THREADS OF THE SLAPHAMMER BROKE OFF INSIDE THE HOLE OF THE FEMORAL TRIAL. AN INSERT IMPACTOR AND MALLET WERE USED TO REMOVE THE TRIAL. REP CONFIRMED THERE WAS ABSOLUTELY NO SURGICAL DELAY. PRIMARY LEFT MEDIAL KNEE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7610755 ↗MalfunctionJun 8, 2018Break; Break
DURING TRAILING THE THREADED TIP OF THE FEMORAL IMPLANT INSERTER BROKE OFF INSIDE THE SIZE 6 LM FEMORAL TRIAL. PKA CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7582220 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.