NA 391.771Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034777269), received between Apr 3, 2017 and Sep 11, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Contamination /Decontamination Problem; Compatibility Problem; Contamination /Decontamination Problem; Compatibility Problem

  IT WAS REPORTED THAT ON 24-AUGUST-2023, THE SHANZ FRAGMENT FROM A PREVIOUS CASE WAS RETAINED INSIDE OF THE HEAD OF THE BOLT CUTTER FOLLOWING USE. IT WAS NOT DISCOVERED BY THE STERILE PROCESSING DEPARTMENT AND WAS NOT REMOVED PRIOR TO RE-STERILIZATION. WHEN THE INSTRUMENT WAS BROUGHT TO THE FIELD, THE RETAINED FRAGMENT FELL FROM THE CUTTER ONTO THE MAYO STAND. THE FRAGMENT DID NOT FALL INTO THE PATIENT. THE CONTAMINATED BOLT CUTTER WAS REMOVED, AND THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720427 ↗
• MalfunctionSep 11, 2023Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INITIAL BOLT CUTTER WAS SHEARING THE ROD, REQUIRING SURGEON ROTATION PAST 180° AND WAS NOT CREATING A CLEAN CUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720192 ↗
• MalfunctionMar 1, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION WITH THE USS SCHANZ FOR THE VERTEBRAL BODY FRACTURE ON (B)(6) 2023. AFTER FINAL LOCKING, WHEN THE SURGEON CUT THE UNNECESSARY PART OF SCREW WITH THE BOLT CUTTING, THE BOLT CUTTING WAS BROKEN. THE BOLT CUTTING COULD NOT BE USED, SO THAT THE HOSPITAL¿S INSTRUMENTS WERE USED FOR CUTTING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE NO WERE ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. PATIENT STATUS/OUTCOME: IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT PRODUCT DETAILS: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY INVOLVED - UNKNOWN). THIS REPORT IS FOR ONE (1) BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461647 ↗
• MalfunctionJun 3, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON CUT TWO SCREWS WITH THE BOLT CUTTING HEAD WITHOUT AN ISSUE. WHEN HE MOVED ON THE 3RD SCREW, HE HAPPENED TO CUT THE SCREW WITH A TWISTING MOTION. THE SEVERED SCREW GOT STUCK EITHER INSIDE THE BOLT CUTTING HEAD OR IN THE LESION. TROUBLESHOOTING WORKED FINE, AND A FRAGMENT WAS REMOVED FROM THE LESION WITHOUT SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597700 ↗
• MalfunctionApr 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHILE CUTTING THE FINAL TRANSPEDICULAR SCHANZ SCREW, THE METAL FRAGMENTS BROKE OFF THE BOLT CUTTING HEAD. NO REPORTS OF THESE FRAGMENTS ENTERING THE OPERATIVE SITE. INSTRUMENT WAS REMOVED FROM THE SET. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753664 ↗
• MalfunctionJul 22, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE NURSE HANDLED THE INSTRUMENT AND DISCOVERED A SMALL PIECE OF THE DEVICE WAS SPLIT FROM THE INSTRUMENT HEAD. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310391 ↗
• MalfunctionJan 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT AN EMERGENCY SURGERY FOR POSTERIOR LUMBAR SPINAL FUSION (L3, L5) TREATING L4 BURST FRACTURE ON (B)(6) 2019. THE EMERGENCY SURGERY WAS PERFORMED. DURING THE PROCEDURE THEY PREPARED THE BOLT CUTTER (391.771) AND FOUND REMNANTS OF A SCHANTZ SCREW. THERE WAS NO KNOWN DELAY. THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593093 ↗
• MalfunctionApr 3, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A T11-L1 POSTERIOR SPINAL FUSION PROCEDURE, WHILE THE SURGEON WAS CUTTING THE SCHANZ PINS AND AFTER ALL OF THE HARDWARE HAD BEEN IMPLANTED, THE HEAD OF A SYNTHES BOLT CUTTER HEAD BROKE AT THE TIP OF THE DEVICE. THE SURGEON RETRIEVED ALL OF THE FRAGMENTS EASILY WITH A DELAY OF APPROXIMATELY ONE MINUTE. A SECOND DEVICE WAS AVAILABLE AND THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCHANZ PIN (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455543 ↗