Equinoxe 301-05-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862530479), received between Sep 21, 2020 and Jul 25, 2023 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY WHEN BROACHING THE SURGEON NOTICED A SMALL PIECE OF METAL INSIDE THE FEMALE PATIENT. AFTER INSPECTION OF THE BROACH HANDLE WE NOTICED THAT THIS HAD COME FROM THE HANDLE. PIECE WAS REMOVED FROM THE PATIENT. THERE WAS A DELAY, NO ADVERSE EVENT OCCURRED DUE TO THIS DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED, UNABLE TO OBTAIN. DEVICE IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388097 ↗
• MalfunctionApr 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING SURGICAL USE, PIECE OF THE BROACH HANDLE BROKE OFF DURING TRIAL BROACH INSPECTION. A PIECE WAS SEEN BY SURGEON RIGHT AWAY. WHEN IT FELL OFF, SURGEON PUT THE PIECE ASIDE WITHOUT ANY ISSUES AT ALL. THIS WAS SIMPLY A BROKEN INSTRUMENT DURING USE IN SURGERY THAT DID NOT HAVE ANY ADVERSE EFFECT. BROKEN PIECES WERE LOCATED AND PUT ASIDE RIGHT AWAY SO NOT PROBLEM AT ALL. NO PROBLEM, NO ISSUES, NO DELAY, NO ADVERSE EFFECT, NO CONCERN OF ANY KIND AS ALL WAS OK. NO PATIENT INFORMATION, NOT IMPLANT RELATED AS ONLY A PIECE OF THE BROACH HANDLE INSTRUMENT BROKE OFF AND IT WAS PUT ASIDE AS NO ISSUES TO THE SURGERY AT ALL. NO PATIENT INFORMATION. PHOTOS ATTACHED. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808266 ↗
• MalfunctionMar 9, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING IMPACTION A LITTLE SLIVER OF METAL BROKE OFF ON THE LEFT SIDE OF THE BROACH HANDLE BETWEEN 0 AND 10 DEGREES OF VERSION. THE BROACH HANDLE WORKS BUT LOSING THAT PIECE OF METAL HAS CREATED A SHARP EDGE. NO PARTS OR PIECES FELL INTO THE PATIENT¿S WOUND SITE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710610 ↗
• MalfunctionNov 9, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED, THE RETROVERSION BAR BECAME STUCK IN 20 DEGREES LEFT SLOT. CROSS THREADED. COULD NOT REMOVE AND ADJUST TO ANY OTHER VERSION DURING SET-UP. PATIENT WAS NOT INVOLVED. NO ISSUES WITH PATIENT UPON LEAVING THE OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778699 ↗
• MalfunctionMar 24, 2021Break; Crack; Break; Crack

  AS REPORTED, DURING A PROCEDURE, THE SURGEON WAS HANDED THE PRESERVE BROACH HANDLE TO BEGIN BROACHING AND FELT A SHARP PIECE OF METAL PIERCE HIS GLOVES. UPON INSPECTION OF THE HANDLE, HE NOTICED THERE WAS DEFECT ON THE LEFT SIDE NEXT TO THE RETROVERSION INSERTS. HANDLE COULDN'T BE USED FOR THE REMAINDER OF THE CASE, SO WE OPENED A BACKUP PRESERVE TRAY. HE INSPECTED THAT HANDLE AND NOTED A SIMILAR DEFECT, NOT QUITE AS SEVERE, IN THE SAME WEAK SPOT OF THE SECOND HANDLE. SHARP, PROTRUDING METAL ON THE LEFT SIDE NEXT TO THE RETROVERSION INSERTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559986 ↗
• MalfunctionMar 24, 2021Break; Crack; Break; Crack

  AS REPORTED, DURING A PROCEDURE, THE SURGEON WAS HANDED THE PRESERVE BROACH HANDLE TO BEGIN BROACHING AND FELT A SHARP PIECE OF METAL PIERCE HIS GLOVES. UPON INSPECTION OF THE HANDLE, HE NOTICED THERE WAS DEFECT ON THE LEFT SIDE NEXT TO THE RETROVERSION INSERTS. HANDLE COULDN'T BE USED FOR THE REMAINDER OF THE CASE, SO WE OPENED A BACKUP PRESERVE TRAY. HE INSPECTED THAT HANDLE AND NOTED A SIMILAR DEFECT, NOT QUITE AS SEVERE, IN THE SAME WEAK SPOT OF THE SECOND HANDLE. SHARP, PROTRUDING METAL ON THE LEFT SIDE NEXT TO THE RETROVERSION INSERTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559985 ↗
• InjuryMar 16, 2021Break; Fracture; Break; Fracture

  AS REPORTED, DURING THE IMPACTION OF A PRESERVE STEM BROACH, THE DOCTOR SUDDENLY STOPPED AND HAD A PIECE OF THE BROACH HANDLE IN HIS HAND. THE PIECE CAME OFF OF THE SIDE OF THE BROACH HANDLE, NOT THE BROACH. HE DID NOT BELIEVE THAT THERE WAS A RETRACTOR PRESSING AGAINST THE BROACH HANDLE AT THE TIME OF IMPACTION. HE REMOVED THE PIECE OF METAL, AND CONTINUED TO IMPACT TO THE NEXT SIZE BROACH, USING THE SAME BROACH HANDLE WITH NO ISSUES. HE FINISHED THE CASE WITH THE SAME BROACH HANDLE AND HAD NO OTHER ISSUES. I AM RETURNING THE BROACH HANDLE FOR FURTHER INSPECTION. THERE WAS NO HARM DONE TO THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496942 ↗
• InjuryFeb 23, 2021Break; Fracture; Break; Fracture

  AS REPORTED, DURING THE IMPACTION OF A PRESERVE STEM BROACH, THE DOCTOR SUDDENLY STOPPED AND HAD A PIECE OF THE BROACH HANDLE IN HIS HAND. THE PIECE CAME OFF THE SIDE OF THE BROACH HANDLE, NOT THE BROACH. HE DID NOT BELIEVE THAT THERE WAS A RETRACTOR PRESSING AGAINST THE BROACH HANDLE AT THE TIME OF IMPACTION. HE REMOVED THE PIECE OF METAL, AND CONTINUED TO IMPACT TO THE NEXT SIZE BROACH, USING THE SAME BROACH HANDLE WITH NO ISSUES. HE FINISHED THE CASE WITH THE SAME BROACH HANDLE AND HAD NO OTHER ISSUES. I AM RETURNING THE BROACH HANDLE FOR FURTHER INSPECTION. THE PIECE OF THE BROACH HANDLE BROKE, FELL INTO THE PATIENT, AND THEN REMOVED BY THE DOCTOR BY HAND. WE HAD TO EXAMINE THE PIECE TO ENSURE IT WAS FROM THE BROACH HANDLE AND THAT EVERYTHING WAS REMOVED PROPERLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11364436 ↗
• InjuryFeb 1, 2021Break; Fracture; Break; Fracture

  AS REPORTED, WHILE BROACHING THE HUMERUS ON THE PATIENT¿S RIGHT SHOULDER WITH THE BROACH HANDLE, THE SURGEON HIT THE BROACH HANDLE AND NOTICED SOMETHING CAME OFF. HE FOUND A PIECE OF METAL HAD BROKEN OFF THE HANDLE, WHICH WAS RECOVERED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETURNED, HOWEVER, A PICTURE WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11262513 ↗
• InjurySep 21, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6) Y/O MALE, A PIECE OF METAL ON THE BROACH BROKE OFF INTO THE PATIENT. THE PIECE OF METAL WAS RECOVERED DURING SURGICAL IMPLANTATION OF IMPLANTS. HAD TO HAVE AN X-RAY TAKEN TO INSURE NO MORE METAL WAS INSIDE THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED. THERE WAS A DELAY OF 15-30 MINUTES TO TAKE THE X-RAY AND ENSURE THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559662 ↗