EIT PLIF Hammer PET60250Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04260397080849), received between Feb 11, 2020 and Dec 24, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (27 reports).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, 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 ↗
• 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 ↗
• MalfunctionFeb 7, 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315701 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON DECEMBER 15, 2022 DURING POST CASE INSPECTION, IT WAS FOUND THAT THE MALLETS WERE NOT STAYING TOGETHER AT THE WELDED THREADS. THERE WAS NO PATIENT INVOLVEMENT. A REPLACEMENT WAS REQUIRED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO MEDICAL INTERVENTION. 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 16137582 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON DECEMBER 15, 2022 DURING POST CASE INSPECTION, IT WAS FOUND THAT THE MALLETS WERE NOT STAYING TOGETHER AT THE WELDED THREADS. THERE WAS NO PATIENT INVOLVEMENT. A REPLACEMENT WAS REQUIRED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO MEDICAL INTERVENTION. 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 16137548 ↗
• MalfunctionDec 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE HAMMER FROM THE CONDUIT EIT AT THE FACILITY NO LONGER HAD THE PLASTIC INSERT. THE PLASTIC HAD SPLIT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AS THE MALLET COULD STILL BE USED. 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 15986626 ↗
• MalfunctionNov 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL INSERTER DEVICES WERE DEFECTIVE. THE CUSTOMER WAS NOT ABLE TO ASSEMBLE THE INSTRUMENTS, AND THE HAMMER SHOWED A FRACTURE. NO PATIENT WAS HARMED, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770015 ↗
• MalfunctionNov 2, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMER WAS ALMOST BROKEN. 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 15713537 ↗
• MalfunctionSep 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOAN SET ARRIVED AT THE LOCAL WAREHOUSE AND IT WAS VERIFIED THAT THE HAMMER WAS BROKEN. 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 15495705 ↗
• MalfunctionMay 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE PLASTIC PART OF THE HAMMER WAS BROKEN. THIS HAD HAPPENED DURING SURGERY. ANOTHER HAMMER WAS USED, SO NO IMPACT FOR SURGERY OR PATIENT. THIS REPORT IS FOR ONE HAMMER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495735 ↗
• MalfunctionMar 26, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INCOMING INSPECTION AT THE LOANER SET DEPARTMENT IT WAS NOTICED THAT THE HANDLE OF THE HAMMER HAS A CRACK. NO SURGERY IMPACT. NO PATIENT IMPACT. 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 13922114 ↗
• MalfunctionMar 19, 2022Break; Break

  DURING A SURGERY A HAMMER FRACTURED AT THE HANDLE AT THE HEIGHT OF THE "H". NO SURGERY IMPACT. NO PATIENT IMPACT. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. NO FRAGMENTS WERE CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827984 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SPINAL FUSION SURGERY THE SURGEON WAS IMPACTING A SPACER INTO THE PATIENTS DISC SPACE WHEN THE PLASTIC END OF THE MALLET BROKE OFF THE MALLET AND FELL IN THE FLOOR. THE SURGEON IMMEDIATELY FLIPPED OVER THE MALLET AND FINISHED THE PROCESS WITH THE METAL END OF THE SAME MALLET. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SPACER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD