NA 03.010.522Recalls & reported problems
Synthes GmbH · SPIRAL COMBINATION HAMMER 500 GRAMS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes Spiral Combination Hammer is a surgical mallet used to drive nails and implants into bone. Reports mostly describe the hammer breaking during surgery, sometimes with the head separating from the shaft or small metal pieces appearing in the field, plus handles and fittings that scratch other instruments or slide loose. There are 70 reports, with 2 injuries and no deaths. 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
- 68
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10886982069344), received between Jun 29, 2018 and May 7, 2026 — classified as 2 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Break” (54 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
- Break54
- Device-Device Incompatibility7
- Contamination /Decontamination Problem3
- Crack2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Corroded1
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient8
- Insufficient Information2
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE T-HANDLE AND LOCKING MECHANISM AND INTERFACE TO THE FINGER REDUCTION TOOL KEEPS SLIDING OFF. THIS WAS WHILE PERFORMING THE FUNCTION BEFORE ASSEMBLING THE SET BEFORE PROCESSING. THE BACK SLAP POLE THAT HELPS REMOVE THE NAIL (THREADS ARE WORN); IT WILL NOT SCREW INTO THE BACK OF THE EXTRACTION BOLT FULLY. IT WAS NOTICED DURING ROUTINE INSPECTION. THE LID TO THE SCREW RACK IN VOLT PHP CAME APART ON ONE SIDE. DRIVING CAPS FOR TNA NAILS HAD A SET PIN MISSING WHICH DOES NOT KEEP THE SPRING IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114749 ↗MalfunctionMay 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE T-HANDLE AND LOCKING MECHANISM AND INTERFACE TO THE FINGER REDUCTION TOOL KEEPS SLIDING OFF. THIS WAS WHILE PERFORMING THE FUNCTION BEFORE ASSEMBLING THE SET BEFORE PROCESSING. THE BACK SLAP POLE THAT HELPS REMOVE THE NAIL (THREADS ARE WORN); IT WILL NOT SCREW INTO THE BACK OF THE EXTRACTION BOLT FULLY. IT WAS NOTICED DURING ROUTINE INSPECTION. THE LID TO THE SCREW RACK IN VOLT PHP CAME APART ON ONE SIDE. DRIVING CAPS FOR TNA NAILS HAD A SET PIN MISSING WHICH DOES NOT KEEP THE SPRING IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114714 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT THE SPIRAL COMBINATION HAMMER 500 GRAMS WAS BROKEN, WITH THE HEAD SEPARATED FROM THE SHAFT. THE EVENT OCCURRED POST-IMPLANT, AND THE DEVICE WAS AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015802 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT THE COMBINED HAMMER 500G AND INSERT-HANDLE HYBRID WERE INVOLVED IN AN INTRA-OPERATIVE EVENT. THE HAMMER BROKE WHILE INSERTING A NAIL, AND A DIFFERENT HAMMER WAS USED, WHICH DID NOT ALLOW BACKSLAPPING. THIS LED TO THE INSERTION HANDLE BEING STRUCK AND SUBSEQUENTLY DAMAGED. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789270 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THE HAMMER BROKE WHILE INSERTING THE TFNA. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756760 ↗MalfunctionMar 9, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF SURGERY WITH TFNAXS AND THE PRODUCTS IN QUESTION. IN THE SURGERY, A TINY PIECE OF METAL WAS DISCOVERED JUST BEFORE THE END CAP WAS INSERTED. IT'S UNCLEAR WHEN OR WHERE IT CAME FROM. NURSES SAY IT CAME FROM THE HAMMER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545536 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE HAMMER HEAD IS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496901 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT ON FEBRUARY 10, 2006, ITEM 03.010.522 BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494432 ↗MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SLOTTED MALLET CENTER TIPS BENT AND WILL NOT FEED OVER A BACKSLAP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428829 ↗MalfunctionJan 30, 2026Break
IT WAS REPORTED THAT A SPIRAL COMBINATION HAMMER BROKE DURING FEMORAL RECON NAILING-ADVANCED (FRNA) SURGERY. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225583 ↗MalfunctionDec 26, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THE PRODUCTS ARE BOTH SCUFFED AND MALLET WILL NOT SLIDE ALONG HAMMER GUIDE ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897233 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MALLET BROKE. TEAM GOT ANOTHER MALLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965110 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT, ON (B)(6) 2025, THE SPIRAL COMBINATION HAMMER BROKE. THE HEAD OF THE HAMMER BROKE OFF AT THE WELD TO THE HANDLE. THIS DID NOT HARM THE PATIENT. THIS DID NOT CAUSE A DELAY OR MORE X-RAYS. THE CASE WAS FINISHED SUCCESSFULLY WITH NO OTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631075 ↗MalfunctionJun 16, 2025Break; Break
IT WAS REPORTED THAT THE MALLET BROKE DURING CASE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213085 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING HANDLES ON THE GT AIMING ARM BROKE OFF AND WON¿T GO BACK ON. THE BLUE MALLET BROKE AT THE WELD. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751904 ↗MalfunctionMar 17, 2025Break; Break
IT WAS REPORTED THAT THE HEAD OF THE MALLET WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621338 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT (B)(6) 2025, THERE WAS A HOLE IN THE RUBBER HANDLE. THE ITEMS WERE FOUND IN POST OP INSPECTION IN SPD CLEAN SIDE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445001 ↗MalfunctionJan 31, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281892 ↗MalfunctionJan 30, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, DURING A TIBIAL NAILING CASE, THE INSTRUMENTS BROKE WHEN REMOVING THE NAIL FROM THE PATIENT AND WERE UNABLE TO BE USED. STAFF OPENED UP A SECOND TIBIAL NAIL TRAY AND WERE ABLE TO COMPLETE THE CASE IN A TIMELY MANNER WITH NO CONSEQUENCES. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272895 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE HAMMER SPLIT WHILE BEING USED. NO DISCOMFORT OF THE SPECIALIST. A DIFFERENT HAMMER WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20677242 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE HEAD OF THE HAMMER SNAPPED OFF THE HANDLE. THERE WAS NO PATIENT CONSEQUENCES AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514825 ↗InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 20439779 ↗MalfunctionOct 11, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A INTRA OPERATIVE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428702 ↗MalfunctionOct 7, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A INTRA OPERATIVE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385592 ↗MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. SURGEON WAS HAMMERING TO INTRODUCE THE HELICAL BLADE WHEN THE HAMMER HEAD RELEASED FROM THE HANDLE. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A SPIRAL COMBINATION HAMMER 500 GRAMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368924 ↗
Other HAMMER, SURGICAL devices
- NA A6779Depuy (Ireland) · HAMMER, SURGICAL128 reports
- SUMMIT 2570-05-250Depuy (Ireland) · HAMMER, SURGICAL100 reports
- NA 399.42Synthes GmbH · HAMMER, SURGICAL39 reports
- NA 399.43Synthes GmbH · HAMMER, SURGICAL37 reports
- NA 03.010.170Synthes GmbH · HAMMER, SURGICAL37 reports
- NA 359.218Synthes GmbH · HAMMER, SURGICAL35 reports
- NA 03.010.056Synthes GmbH · HAMMER, SURGICAL27 reports
- GLOBAL ADVANTAGE 2128-01-025Depuy (Ireland) · HAMMER, SURGICAL23 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.
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