EIT PLIF HammerRecalls & reported problems across all models

We found 2 models of EIT PLIF Hammer by EIT Emerging Implant Technologies GmbH in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2020 and Dec 24, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EIT PLIF Hammer problems

EIT PLIF Hammer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EIT PLIF Hammer PET60250

  Orthopedic Manual Surgical Instrument
  30 reports
• EIT PLIF Hammer PET60251

  Orthopedic Manual Surgical Instrument
  2 reports

Recent EIT PLIF Hammer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025 DURING A TLIF PROCEDURE IN A MIS DEGENERATIVE CASE, THERE WAS AN ISSUE WITH THE HAMMERS. DURING INSERTION OF THE CAGE, THE HAMMER WAS USED TO POSITION THE CAGE IN THE DISC SPACE. THE SURGEON NOTICED THAT THE HAMMER FELT STRANGE AND UPON INSPECTION WITH THE SCRUB NURSE, IT WAS NOTICED THAT THE SHAFT OF THE HAMMER WAS BROKEN. THIS HAS HAPPENED WITH ANOTHER HAMMER IN THIS CLINIC AS WELL. THERE WAS NO EXCESSIVE FORCE OR HAMMERING USED, THE CAGES WAS POSITIONED AS USUAL. THE SURGEON IS WELL TRAINED IN THE PROCEDURE AND PREFORMS THIS SURGERY SEVERAL TIME AS A WEEK. NO CAUSE FOR THE FRACTURE WAS FOUND IN THE SURGICAL PROCEDURE. EVENT WAS NOTICED INTRA OPERATIVELY, BUT IT IS ASSUMED THAT THE HAMMER WAS ALREADY BROKEN AT THE START OF THE SURGERY. ANOTHER HAMMER WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887864 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025 DURING A TLIF PROCEDURE IN A MIS DEGENERATIVE CASE, THERE WAS AN ISSUE WITH THE HAMMERS. DURING INSERTION OF THE CAGE, THE HAMMER WAS USED TO POSITION THE CAGE IN THE DISC SPACE. THE SURGEON NOTICED THAT THE HAMMER FELT STRANGE AND UPON INSPECTION WITH THE SCRUB NURSE, IT WAS NOTICED THAT THE SHAFT OF THE HAMMER WAS BROKEN. THIS HAS HAPPENED WITH ANOTHER HAMMER IN THIS CLINIC AS WELL. THERE WAS NO EXCESSIVE FORCE OR HAMMERING USED, THE CAGES WAS POSITIONED AS USUAL. THE SURGEON IS WELL TRAINED IN THE PROCEDURE AND PREFORMS THIS SURGERY SEVERAL TIME AS A WEEK. NO CAUSE FOR THE FRACTURE WAS FOUND IN THE SURGICAL PROCEDURE. EVENT WAS NOTICED INTRA OPERATIVELY, BUT IT IS ASSUMED THAT THE HAMMER WAS ALREADY BROKEN AT THE START OF THE SURGERY. ANOTHER HAMMER WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887861 ↗
• MalfunctionAug 26, 2025Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRE OPERATIVE EVENT. ANOTHER MALLET WAS USED, AND THERE WERE NO ISSUES; THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893635 ↗
• MalfunctionAug 5, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE INSERTER PRODUCTS ARE WORN DUE TO FREQUENT USE AND NEED REPLACEMENT. THE HAMMER BROKE AND HAS A CRACK LINE. THE INSERTER KNOB HAS CORRODED THREADS AND IT IS NOT POSSIBLE TO FIT INTO THE OUTER SHAFT. THE TRIAL IS THE OLD REFERENCE SO IT DOESN¿T ALLOW CONNECTION WITH THE NEW OUTER AND INNER SHAFTS. ANOTHER TRIAL WAS WORN OUT AND ROTATED RELATIVE TO THE OUTER SHAFT WHILE IT WAS COMPLETELY CLOSED. THERE WAS NO PATIENT CONSEQUENCE. ISSUES WERE NOTED PREOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714214 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE OF THE HAMMER BROKE WHILE INSERTING CONDUIT CAGE. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926072 ↗
• MalfunctionApr 22, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON FEBRUARY 7, 2024, THE CUSTOMER REPORTED THAT THE LSY EXPEDIUM VIPER LOANER ORTHOKIT SET CAME WITH ONE OF THE EJECTORS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE LASER WELD NEAR THE INTERFACE AND THE ROD WAS BROKEN; FRAGMENTS STILL ATTACHED. THIS REPORT IS FOR A SLAP-HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153181 ↗
• MalfunctionMar 25, 2024Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE CONDUIT HAMMER IN QUESTION BROKE. NO FRAGMENTS WERE GENERATED, THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970414 ↗
• MalfunctionMar 18, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER BROKE DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ANOTHER HAMMER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) HAMMER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923739 ↗
• MalfunctionMar 18, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER BROKE DURING A PROCEDURE PERFORMED ON (B)(6), 2024. ANOTHER HAMMER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) HAMMER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923732 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT ON DECEMBER 21, 2023, DURING POSTOP INSPECTION, IT WAS NOTED THAT THE INNER THREADS ON THE CONDUIT PLUF INSERTER AND INNER SHAFT WERE DAMAGED TO THE POINT OF NOT FUNCTIONING. ALSO, THE PLASTIC TIP OF THE MALLET WAS BROKEN OFF, LEAVING THE THREADS BEHIND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT INVOLVES ONE HAMMER. THIS IS REPORT 3 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503157 ↗
• MalfunctionNov 9, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THEY NOTICED THAT THE THREADS ON THE PLASTIC PORTION OF THE HAMMER HAD SNAPPED, SO THE END PORTION OF THE WHITE PLASTIC BIT OF THE HAMMER WAS MISSING. NO DELAY, AS NOTICED OUTSIDE OF SURGERY, SURGEON: NO SURGEON WAS NOTICED OUTSIDE OF SURGERY. NO PATIENT WAS AFFECTED; THE ISSUE WAS NOTICED PRE-OP. THIS REPORT IS FOR ONE (1) HAMMER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099615 ↗
• MalfunctionOct 3, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6), 2023, THE SALES CONSULTANT WAS MADE AWARE THAT A HAMMER HAD A FRACTURED SHAFT, WHICH WAS IDENTIFIED AFTER THE ITEM WENT THROUGH DECONTAMINATION. THERE WAS NO PATIENT HARM. THE ITEM WAS REMOVED FROM USE. THIS REPORT INVOLVES ONE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862667 ↗
• MalfunctionSep 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER ARRIVED DAMAGED TO THE LOCAL DISTRIBUTION CENTER. THE ISSUE WAS DISCOVERED DURING INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815924 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, THE SURGEON WAS USING THE PLIF HAMMER TO PROPERLY PLACE A SPACER IN THE PATIENT¿S DISC SPACE USING THE PLASTIC CAP END OF THE HAMMER. UNFORTUNATELY, THE PLASTIC CAP WAS NOT SCREWED ON COMPLETELY AND BROKE UPON IMPACT WITH THE SPACER HOLDER. THE SURGEON STOPPED FOR A MOMENT AND THEN FLIPPED THE HAMMER OVER USING THE SOLID METAL END TO FINISH THE SPACER PLACEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) HAMMER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301911 ↗
• MalfunctionFeb 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A CRACK IN THE METAL SHAFT OF THE HAMMER ONE CENTIMETER FROM THE SILICONE HANDLE. WATER COMES FROM THE CRACK AFTER CLEANING, SO IT IS NOT POSSIBLE TO STERILIZE THE INSTRUMENT. THE ISSUE WAS DISCOVERED IN THE STERILE DEPARTMENT DURING CLEANING POST SURGERY. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE SURGERY WAS PERFORMED AS PLANNED WITH NO DELAY. THIS REPORT INVOLVES ONE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430583 ↗

Other EIT Emerging Implant Technologies GmbH products

• EIT TLIF Inserter4 models · 140 reports
• EIT CIF cage6 models · 14 reports · 2 recalls
• EIT LLIF Inserter2 models · 60 reports
• EIT PLIF Inserter3 models · 40 reports
• EIT ALIF Inserter3 models · 25 reports