EVOS 71175022Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00885556635766), received between Jan 19, 2018 and Mar 31, 2026 — classified as 25 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE. THE BROKEN BIT WAS LEFT INSIDE THE PATIENT. IT REMAINED IMPLANTED. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK UP PRODUCT. PATIENT WENT TO RECOVERY POST OPERATIVELY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24742484 ↗
• InjuryNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN OSTEOSYNTHESIS SURGERY, DURING DRILLING ONE (1) EVOS SMALL 2.5MM DRILL W/AO QC LONG FRACTURED AND THE PIECE REMAINED INSIDE THE BONE OF THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23622068 ↗
• MalfunctionNov 14, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TIBIA AND FIBULA FRACTURE SURGERY, ONE (1) EVOS SMALL 2.5MM DRILL W/AO QC LONG WAS DULL, AND THE DOCTOR APPLIED TOO MUCH FORCE WHILE DRILLING, CAUSING IT TO BREAK. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556419 ↗
• MalfunctionNov 14, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TIBIA AND FIBULA FRACTURE SURGERY, ONE (1) EVOS SMALL 2.5MM DRILL W/AO QC LONG WAS DULL, AND THE DOCTOR APPLIED TOO MUCH FORCE WHILE DRILLING, CAUSING IT TO BREAK. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556265 ↗
• InjuryJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE OFF IN PATIENT BONE. ONE PIECE OF THE DRILL BIT STAYED BEHIND IN THE PATIENT BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 22464907 ↗
• InjuryDec 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A LEFT TIBIA AND FIBULA INTERNAL FIXATION, THE 2.5MM DRILL BIT TIP MEASURING 3CM BROKE INTO THE LEFT TIBIA WHILE SURGEON WAS USING DRILL BIT FOR PROCEDURE. SURGEON ATTEMPTED TO REMOVE DRILL BIT, BUT WAS UNSUCCESSFUL AT REMOVING FROM PATIENT'S BONE. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20950453 ↗
• InjuryApr 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE. IT WAS USED IN THE APPROPRIATE MANNER THROUGH A LOCKING DRILL GUIDE. THE BROKEN DRILL BIT PIECE - APPROXIMATELY 15MM OF THE DISTAL END COULD NOT BE RETRIEVED FROM THE PATIENTS TIBIA DESPITE SEVERAL ATTEMPTS. METHODS TO RETRIEVE THE BROKEN PART WERE UNSUCCESSFUL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16735151 ↗
• InjuryFeb 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, WHEN FINISHING THE DRILLING PROCESS, IT WAS IDENTIFIED THAT THE TIP OF THE EVOS SMALL 2.5MM DRILL W/AO QC LONG DEVICE HAD BROKEN WHEN IT TOUCHED THE ROD. THE DRILL TIP WAS NOT REMOVED, IT REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16427671 ↗
• InjuryDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, AFTER THE DRILLING, THE TIP OF THE EVOS SMALL 2.5MM DRILL W/AO QC LONG HAD BROKEN WHEN IT TOUCHED THE NAIL. THE TIP OF THE DRILL WAS NOT REMOVED, IT REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15921706 ↗
• InjurySep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE INSIDE THE PATIENT¿S BONE. THE BROKEN DRILL BIT END WAS LEFT INSIDE THE PATIENT¿S TIBIA. SURGERY WAS PERFORMED WITH A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS DISCHARGED AND IS RECOVERING NORMALLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15426375 ↗
• InjurySep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN OPEN REDUCTION AND INTERNAL FIXATION TO THE RIGHT SHOULDER, WHILE USING EVOS SMALL 2.5MM DRILL W/AO QC LONG, IT BROKE OFF IN HUMERAL HEAD. A CLINICAL DECISION WAS MADE TO LEAVE THE DRILL BIT IN PLACE. IT IS UNKNOWN HOW SURGERY WAS RESUMED AND IF THERE WAS ANY DELAY IN CONSEQUENCE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 15392977 ↗
• MalfunctionAug 19, 2022Break; Entrapment of Device

  SURGEON WAS USING DRILL DURING SURGERY; DRILL BIT BROKE OFF IN HUMERAL HEAD DURING USE. CLINICAL DECISION WAS MADE TO LEAVE THE DRILL BIT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15257887 ↗
• InjuryJul 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A FRACTURE OF THE TIBIAL PLATEAU PROCEDURE, WHEN DRILLING THE BONE, THE FIRST EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE IN THE PATIENT AND THE SECOND EVOS SMALL 2.5MM DRILL W/AO QC LONG WAS BENT. INCIDENT OCCURRED WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136782 ↗
• InjuryMay 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, A EVOS SMALL 2.5MM DRILL W/AO QC LONG BIT BROKE INSIDE PATIENT WHILE DRILLING. PIECE WAS UNABLE TO BE REMOVE FROM PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK UP DEVICE. PATIENT HAS A FOREIGN BODY INSIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14520031 ↗
• InjuryApr 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF OF A RIGHT TIBIAL PLATEAU FRACTURE, THE EVOS SMALL 2.5MM DRILL W/AO QC LONG FRACTURED IN THE BONE. FRAGMENT WAS UNABLE TO BE REMOVED. CLINICAL DECISION WAS MADE THAT THE RISKS OF REMOVING THE FRAGMENT OUTWEIGHED THE BENEFITS OF REMOVING. SURGERY WAS RESUMED WITH A BACK-UP DEVICE AND WITHOUT ANY DELAY. NO HARM TO THE PATIENT HAS BEEN NOTED BEYOND WHAT WAS DESCRIBED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14247408 ↗
• InjuryApr 11, 2022Break; Break

  IT WAS REPORTED THAT THE EVOS SMALL 2.5MM DRILL W/AO QC LONG WAS BROKEN AND THE SURGEON DECIDED TO LEAVE IT INSIDE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14072042 ↗
• MalfunctionMar 25, 2022Break; Difficult to Remove

  DURING PROCEDURE, 1" OF A 2.5 DRILLBIT BROKE IN THE BONE. FRAGMENT WAS UNABLE TO BE REMOVED. CLINICAL DECISION WAS MADE THAT THE RISKS OF REMOVING THE FRAGMENT OUTWEIGHED THE BENEFITS OF REMOVING.

  Patient problems: Foreign Body In Patient

  MAUDE report 13901013 ↗
• InjuryNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, WHILE DRILLING THE BONE AN EVOS SMALL 2.5MM DRILL W/AO QC LONG ENTERED IN CONTACT WITH ANOTHER SCREW, AND ENDED UP BREAKING THE TIP, WHICH STAYED INSIDE. THE PHYSICIAN CONFIRMED THAT WOULD HAVE NO PROBLEM WITH THE TIP STAYING IN THE BONE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 12848740 ↗
• InjuryMay 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, AN EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE IN PATIENT'S RIGHT TIBIA. INSTRUMENT WAS LEFT INSIDE OF THE PATIENT BECAUSE IT WOULD CAUSE MORE HARM THAN GOOD TO PATIENT TO RETRIEVE DRILL BIT. X-RAY FOR FOREIGN BODY WAS OBTAINED AND READ BY RADIOLOGIST BUT IT WAS NEGATIVE FOR FOREIGN BODY (UNABLE TO VISUALIZE O X-RAY). IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF IT WAS DELAYED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 11784292 ↗
• MalfunctionApr 22, 2021Break; Difficult to Remove

  A ONE INCH PIECE OF 2.5 MM DRILL BIT BROKE OFF DEEP IN THE TIBIA BONE. THE SURGEON OPTED TO LEAVE THE BROKEN PIECE AS IT WOULD BE MORE DETRIMENTAL TO PATIENT TO TRY TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11705967 ↗
• MalfunctionMar 22, 2021Break; Entrapment of Device

  DURING PROCEDURE TIP OF SMITH AND NEPHEW DRILL BIT (7117-5022) BROKE IN PATIENTS RIGHT TIBIA. SURGEON DETERMINED IT WOULD CAUSE MORE HARM THAN GOOD TO PATIENT TO RETRIEVE DRILL BIT. X-RAY FOR FOREIGN BODY OBTAINED AND READ BY RADIOLOGIST NEGATIVE FOR FOREIGN BODY (UNABLE TO VISUALIZE ON X-RAY).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11541782 ↗
• MalfunctionMar 14, 2021Break; Break

  IT WAS REPORTED THAT DURING ANKLE PROCEDURE THE EVOS SMALL 2.5 DRILL W/AO QC LONG BROKE OUTSIDE THE PATIENT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478837 ↗
• InjuryAug 26, 2020Break; Break

  IT WAS REPORTED THAT, DURING A BIG TIBIAL PLATEAU SURGERY, THE EVOS SMALL 2.5MM DRILL W/AO QC LONG BROKE, INTERNAL TO PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10453548 ↗
• InjuryAug 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, DRILL BIT BROKE OFF INSIDE PATIENT'S TIBIA SHAFT WHEN DRILLING THROUGH LOCKING TOWER FOR A 3.5 LOCKING SCREW. TIP OF DRILL BIT COULD NOT BE REMOVED AND WAS LEFT IN PATIENT. A DELAY GREATER THAN 30 MINUTES REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10428082 ↗
• MalfunctionMay 13, 2020Break; Break

  IT WAS REPORTED THAT A 2.5MM DRILL W/AO QC LONG BROKE WHILE ADDRESSING A MEDIAL MALLEOLUS FRACTURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF SURGERY WAS DELAYED AS CONSEQUENCE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051740 ↗