Hall® Titan™ Primecut+™ PRO9350BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 40845854050805), received between Jun 14, 2022 and Dec 10, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE PRO9350B HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE WAS BEING USED ON APPROXIMATELY 19NOV25 AND THE ¿¿OSCILLATOR HEAD ASSEMBLY STOPS ROTATING WHEN IT HITS BONE.¿¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768865 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO9350B HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE WAS BEING USED ON (B)(6) 2025 DURING A RIGHT TOTAL ANTERIOR HIP AND THE ¿HEX NUT ON SAW BROKE OFF YESTERDAY IN A PATIENT, ALL PARTS WERE RECOVERED, AND NO NEGATIVE PATIENT OUTCOME HAPPENED¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468533 ↗
• MalfunctionDec 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE PRO9350B HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE WAS BEING USED ON AN UNKNOWN DATE DURING A KNEE REPLACEMENT OPERATION AND THE ¿SAW STOPS WHEN THERE IS RESISTANCE¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF A ¿COUPLE OF MINUTES, NEW SAW WAS TAKEN¿. THE PATIENT¿S CONDITION WAS REPORTED AS ¿RECOVERING FROM SURGERY ¿NORMAL STATUS¿.¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989100 ↗
• MalfunctionNov 21, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE DEVICE, PRO9350B, HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE WAS BEING USED AND THE ¿HOUSING SEEMS LOOSE AND SLOWS DOWN WHEN BLADE HITS BONE¿. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745182 ↗
• InjurySep 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  A SERVICE REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE (B)(4), HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE DEVICE WAS BEING USED DURING HIP REPLACEMENT SURGERY ON (B)(6) 2024, AND ¿THE SAW FREEZES WHEN AGAINST HARD BONE AND THAT A FRACTURE OCCURRED IN THE SAW WHEN IT FROZE IN THE MIDDLE OF SAWING.¿. FOLLOW-UP ASSESSMENT FOUND THAT "THE FINNISH WORD FOR FRACTURE CAN ALSO BE TRANSLATED AS FAULT, SO NOW WITH MORE INFORMATION THAT IS THE BETTER WORD. NOTHING CAME OFF THE SAW. THE PROBLEM WAS THAT WHEN THE SAW BLADE MADE CONTACT WITH THE BONE, THE MOVEMENT OF THE SAW BLADE STOPPED, I.E. SAWING STOPPED, BUT THE SOUND WAS HEARD. THE SAW HAD TO BE DRAGGED BACK AND FORTH, BECAUSE THE SAWING STOPPED WHEN IT HIT HARDER BONE. AS IF THE SAW DIDN'T HAVE ENOUGH TORQUE TO MOVE THE SAW BLADE. WHEN REMOVING THE CAPUT, IT WAS NOTICED THAT THE NECK HAD NOT BEEN SAWED OFF COMPLETELY, BUT A PIECE OF THE FEMUR BROKE OFF WHEN REMOVING IT (THE CAPUT WAS STILL ATTACHED TO A SMALL PART, WHICH WAS NOT VISIBLE). A SMALL PIECE BROKE FROM THE FEMUR, A DALL-MILES WIRE INSERTED JUST IN CASE. DALL-MILES WIRE PUT IN, SETTLED NORMALLY". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF

  Patient problems: Bone Fracture(s)

  MAUDE report 20191174 ↗
• MalfunctionMar 20, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO9350B, HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE DEVICE WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿THE OSCILLATOR HEAD OF THE MAIN BODY WAS CUT OFF DURING OSTEOTOMY USING THIS HALL TITAN PRIMECUT+ OSCILLATOR. " FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED USING ¿INSTRUMENT LIKE FORCEPS¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE "BACKUP INSTRUMENT" AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿NO PROBLEM¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577186 ↗
• MalfunctionJun 14, 2022Fracture; Fracture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO9350B, HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE, WAS BEING USED DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE ¿TITAN POWERTOOL FRACTURED AND BROKE APART DURING USE¿. FURTHER ASSESSMENT FOUND THE SURGEON WAS MAKING THE TIBIAL CUT WHEN THE HANDPIECE BROKE APART, THE DEVICE FRAGMENTED IN THE STERILE FIELD BUT NOT INTO THE PATIENT¿S SURGICAL SITE. THE PATIENT WAS NOT INJURED AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION NEEDED FOR THE PATIENT. THE PATIENT WAS DISCHARGED. NO ALTERNATE DEVICE WAS USED AND THERE WAS 15 MINUTE DELAY TO THE SURGERY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685996 ↗