NA 388.72Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034773759), received between Feb 22, 2017 and Jul 28, 2025 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (19 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE BOLT CUTTER WAS RECEIVED INTO DECONTAMINATION FROM THE OPERATING ROOM AND UPON INSPECTION IT WAS NOTED THAT THE CUTTING EDGE WAS CHIPPED AND APPEARED TO BE SPLITTING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631962 ↗
• MalfunctionSep 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE ITEM NEEDED TO BE REPAIRED. IT WAS BROKEN/CHIPPED AT THE CUTTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258344 ↗
• MalfunctionAug 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JULY 18, 2024, WHILE THE SURGEON WAS CUTTING SCHANZ SCREWS FROM THE LARGE EXTERNAL FIXATION SET DURING APPLICATION OF THE EXTERNAL FIXATOR TO A FRACTURED ANKLE, THE BOLT CUTTER BLADE BROKE BUT STILL SUCCESSFULLY CUT THE ROD. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996204 ↗
• MalfunctionMay 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED INTRA-OPERATIVELY ON AN UNKNOWN DATE, THE ROD CUTTER BLADES CHIPPED. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19219829 ↗
• MalfunctionMar 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE EQUIPMENT ROOM FACILITATOR WAS BROUGHT THE BOLT CUTTER 388.72 BY THE INSTRUMENT ROOM TECHNICIAN. IT WAS POINTED OUT THAT THE BOLT CUTTER HAD A DAMAGED TIP. THE FRAGMENT WAS NOT IN HER POSSESSION. THE SURGEON WAS CUTTING THE TITANIUM ROD ON THE BACK TABLE. AFTER CUTTING OF ROD THEY SENT THE ROD CUTTER DOWN TO INSTRUMENT ROOM. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE ROD CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934484 ↗
• MalfunctionNov 24, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON OCTOBER 31, 2023, THAT THE ROD CUTTER CUTTING BLADES CHIPPED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) ROD CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18205376 ↗
• MalfunctionJul 31, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2023, THAT THERE WAS DAMAGED UPON OPENING. IT WAS CRACKED AND SHATTERED. THIS REPORT IS FOR ONE (1) ROD CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424676 ↗
• InjuryMay 11, 2023Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSIDE ROD CUTTER: BLADE OF ROD CUTTER SHATTERED WHILE CUTTING ROD INSIDE PATIENT. CAUSING METAL FRAGMENTS INSIDE PATIENT. TWO (2) OF THE CUTTERS DID THE SAME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) ROD CUTTER THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16916236 ↗
• InjuryMay 11, 2023Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSIDE ROD CUTTER: BLADE OF ROD CUTTER SHATTERED WHILE CUTTING ROD INSIDE PATIENT. CAUSING METAL FRAGMENTS INSIDE PATIENT. TWO (2) OF THE CUTTERS DID THE SAME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16915613 ↗
• MalfunctionApr 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CUTTING BLADES OF THE ROD CUTTER CHIPPED THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) ROD CUTTER THIS IS REPORT 1 OF 2 FOR COMPLAINT \(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814808 ↗
• MalfunctionApr 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CUTTING BLADES OF THE ROD CUTTER CHIPPED THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814803 ↗
• MalfunctionMar 31, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BOLT CUTTER WAS BROKEN AND RETURNED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657444 ↗
• MalfunctionAug 18, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF BLADES BROKE OFF. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD CUTTER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248994 ↗
• MalfunctionAug 18, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED TWO (2) ROD CUTTERS BROKE INTRAOPERATIVELY ON AN UNKNOWN DATE. TIPS OF BLADES BROKE OFF. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO KNOWN PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A ROD CUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248801 ↗
• MalfunctionDec 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE ROD CUTTER WAS CHIPPED WHILE CUTTING A ROD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113033 ↗
• MalfunctionSep 8, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE PIN CUTTER BLADE WAS CHIPPED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442545 ↗
• MalfunctionJun 24, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CUTTER BLADE ON THE LARGE PIN CUTTER IS CHIPPED. IT WAS UNKNOWN THAT HOW IT HAPPENED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ROD CUTTER THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059048 ↗
• MalfunctionApr 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, AN INSTRUMENT BROKE WHILE CUTTING A ROD. ANOTHER ROD CUTTER WAS RETRIEVED AND USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745389 ↗
• MalfunctionApr 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A SPINAL FUSION PROCEDURE DUE TO UNKNOWN REASON. DURING THE PROCEDURE, THE ROD CUTTER FRACTURED WHILE CUTTING ROD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ROD CUTTER THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637871 ↗
• MalfunctionDec 18, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE ROD CUTTER BROKE. THERE WAS NO FRAGMENT GENERATED FROM THE BROKEN DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS WAS OKAY. THIS REPORT INVOLVES 1 ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036266 ↗
• MalfunctionOct 5, 2020Break; Break

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SURGEON HAD TO CUT A STAINLESS STEEL NEEDLE AND DAMAGED THE DISTAL TIP OF THE ROD CUTTER BLADES. THE ROD CUTTER HAD BEEN RECENTLY PURCHASED AND WAS DAMAGED THE FIRST TIME IT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO IMPACT ON THE PATIENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10631632 ↗
• MalfunctionSep 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6)2020, DURING A SPINAL FUSION PROCEDURE, THE ROD CUTTER CHIPPED WHILE CUTTING A COBALT CHROME 5.5 ROD. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN COBALT CHROME 5.5 ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521899 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION OF SETS, ONE (1) BOLT CUTTER CUTTING EDGE WAS CHIPPED, TWO (2) DEPTH GAUGE OUTER SLEEVE FALLS OFF DUE TO MISSING BEARING, ONE (1) DEPTH GAUGE HAS A BROKEN TIP, ONE (1) GUIDE SLEEVE HAS A BROKEN/BENT TIP, ONE (1) CANNULATED STARDRIVE TWISTED TIP, TWO (2) SCREWDRIVERS HAS A BROKEN TIP. ONE (1) DRIVING CAP HAS A BROKEN TIP, ONE (1) EXTRACTION INSTRUMENT WAS STRIPPED INSERTION THREADS, ONE (1) HANDLE WITH QUICK COUPLING HAS A BROKEN HANDLE, ONE (1) HANDLE SLEEVE WITH UNKNOWN ALLEGATION: ONE (1) TORQUE LIMITER AND ONE (1) TENSION HOLDER DRIVER WON'T LOCK, AND ONE (1) DRILL SLEEVE HAS AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIFTEEN (15) DEVICES. THIS REPORT IS FOR (1) BOLT CUTTER THIS IS REPORT 1 OF 8 (B)(4) RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497249 ↗
• MalfunctionJul 6, 2020Break; Break

  IT WAS REPORTED THAT DURING A T12-14 POSTERIOR FUSION ON (B)(6) 2020, THE TEETH OF THE ROD CUTTER WERE FOUND TO BE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER ROD CUTTER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10234213 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. DURING THE PROCEDURE, A ROD CUTTER BROKE WHILE CUTTING A ROD ON THE BACK TABLE. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143282 ↗