NA 323.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 309 adverse event reports that list this exact device (DI 10886982190758), received between Feb 15, 2017 and Aug 19, 2026 — classified as 80 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Break” (196 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 309 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326864 ↗
• MalfunctionMay 21, 2026Break

  THE CUSTOMER REPORTS THAT THE HANDLE BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241372 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A 2.0MM DRILL BIT WITH DOUBLE MARKINGS BROKE WHILE DRILLING INTO THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592384 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 AND K-WIRE Ø1.6 W/DRILL TIP L200 WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING THE REVIEW OF IMPLANTS AFTER SURGERY, THE K-WIRE WAS OBSERVED TO BE DOUBLED, AND THE DRILL BIT BROKE DURING THE PROCEDURE. THE DETACHED PART WAS REMOVED, AND THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558888 ↗
• MalfunctionMar 9, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT STAGBEETLE FORCEPS, RATCHET LOCK, LENGTH 125 MM, AND DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING SURGERY, THE DRILL BIT BROKE WHILE DRILLING TO PLACE THE LAST SCREW, AND THE BROKEN FRAGMENT REMAINED INTRAMEDULLARY AS IT COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT CHANGES TO THE SCHEDULE, AND IT WAS INDICATED THAT THE RETAINED FRAGMENT WOULD NOT CAUSE PROBLEMS. IN A SEPARATE INCIDENT DURING THE SAME PROCEDURE, THE STAGBEETLE FORCEPS BROKE INTO SEVERAL PIECES WHILE REDUCING AN ELBOW FRAGMENT. THE BROKEN FORCEPS WERE IMMEDIATELY REPLACED WITH ANOTHER PAIR FROM THE SURGICAL KIT, ALLOWING THE PROCEDURE TO CONTINUE WITHOUT DELAY OR PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24544971 ↗
• MalfunctionMar 2, 2026Break

  THE DRILL ARRIVED WITHIN THE SET BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 24483017 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE DRILL BIT WAS SKEWED AND IT WAS DIFFICULT TO PASS THROUGH THE TOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097045 ↗
• MalfunctionJan 9, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT TWO (2) 2.0 DRILL BITS BROKE IN HUMERUS DURING PROCEDURE. THE BROKEN DRILL BIT WAS LEFT IN THE PATIENT AND THE SURGEON DECIDED TO TAKE NO ACTION ON BROKEN DRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24027986 ↗
• MalfunctionJan 9, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT TWO (2) 2.0 DRILL BITS BROKE IN HUMERUS DURING PROCEDURE. THE BROKEN DRILL BIT WAS LEFT IN THE PATIENT AND THE SURGEON DECIDED TO TAKE NO ACTION ON BROKEN DRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24027984 ↗
• MalfunctionDec 23, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE, WHEN DRILLING TO PLACE ONE OF THE 2.7 LOCKING SCREWS, THE 2.0 BIT BROKE, WITHOUT FINDING THE TIP. WE PROCEED TO TAKE X-RAY IMAGES, SHOWING THAT THE FRAGMENT IS INSIDE THE PATIENT'S BONE. DR. TRIES TO REMOVE THIS FRAGMENT, BUT IT WAS NOT POSSIBLE AND DECIDES TO LEAVE THIS TIP BECAUSE OF THE DIFFICULT EXTRACTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23877930 ↗
• MalfunctionDec 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3, DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE F/, AND K-WIRE Ø1 L150 SST WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING THE PROCEDURE, SHORTAGES OF A 2.0 DRILL BIT AND A 1.0 K-NEEDLE WERE IDENTIFIED UPON OPENING THE EQUIPMENT. LATER, THE 2.0 DRILL BIT BROKE, LEAVING ITS TIP EMBEDDED IN THE PATIENT'S BONE. THE FRAGMENT COULD NOT BE REMOVED AND WAS INTENTIONALLY LEFT IN PLACE, AS IT WAS DETERMINED THERE WOULD BE NO ADVERSE CONSEQUENCE. THE REMAINING PORTION OF THE DRILL BIT WAS REMOVED, AND A REPLACEMENT DRILL BIT WAS USED TO COMPLETE THE SURGERY WITHOUT DELAY OR DISCOMFORT TO THE SPECIALIST.

  Patient problems: Foreign Body In Patient

  MAUDE report 23829243 ↗
• MalfunctionDec 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE DRILL WAS COMPLETELY BENT. IT WAS NOTED DURING SURGERY. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788021 ↗
• MalfunctionDec 10, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE 2.0 MM DRILL BITS BROKE DURING SURGERY; ONE PIECE REMAINED INSIDE THE PATIENT'S BONE, WHILE THE OTHER IS SENT INTACT. SCREWS WITH DAMAGED HEADS ARE NOT USED IN SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23771259 ↗
• MalfunctionDec 10, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE 2.0 MM DRILL BITS BROKE DURING SURGERY; ONE PIECE REMAINED INSIDE THE PATIENT'S BONE, WHILE THE OTHER IS SENT INTACT. SCREWS WITH DAMAGED HEADS ARE NOT USED IN SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23771249 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR WAS DRILLING INTO THE DISTAL TIBIA. THE PATIENT HAD SCREWS MADE OF A MATERIAL THAT BROKE WHEN THE PREVIOUS PLATE WAS REMOVED. THE DRILL BIT STRUCK ONE OF THESE SCREWS AND BROKE OFF AT THE TIP. THE BROKEN PIECE WAS REMOVED WITHOUT AFFECTING THE PATIENT AND REPLACED WITH ANOTHER DRILL BIT OF THE SAME TYPE, ALSO INCLUDED IN THE KIT. THE SURGERY WAS THEN SUCCESSFULLY COMPLETED WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTING THE PATIENT, AND WITHOUT DELAYS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714320 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT WHEN CLEANING THE DRILL BIT IT HAD SNAPPED OFF THE DRILL. THE DRILL BIT ON THE TRAY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524258 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT THE 2.0MM DRILL BIT WAS FRACTURED DURING THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO DAMAGE TO THE PATIENT, ALL FRAGMENTS WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058083 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT TWO DRILL BITS OF 2.0MM REFERENCE WERE BROKEN INTRA-OPERATIVELY; ONE OF THE PARTS OF THE DRILL BIT REMAINED IN THE PATIENT, DID NOT AFFECT THE PATIENT OR THE SURGICAL PROCEDURE WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963362 ↗
• MalfunctionSep 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT TWO DRILL BITS OF 2.0MM REFERENCE WERE BROKEN INTRA-OPERATIVELY; ONE OF THE PARTS OF THE DRILL BIT REMAINED IN THE PATIENT, DID NOT AFFECT THE PATIENT OR THE SURGICAL PROCEDURE WAS PROLONGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22963314 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT THE 2.0 BIT WAS BROKEN DURING A PROCEDURE. ANOTHER DRILL BIT WAS USED. THIS DID NOT AFFECT THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963240 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PREOPERATIVE PERIOD, THE DRILL BIT BROKE IN TWO WHEN THE SCREWS WERE FITTED. THE TWO PIECES OF THE DRILL BIT WERE RECOVERED DIRECTLY. NO CONSEQUENCE FOR THE PATIENT BECAUSE THE DRILL BIT HAD NOT REMAINED IN SITU. RISK OF METAL BREAKAGE IN THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939538 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE A 2.0MM DRILL BT BROKE WHILE DRILLING. THE BIT TOGETHER WITH ITS FRAGMENTS WAS REMOVED AND ANOTHER DRILL BIT OF THE SAME CHARACTERISTICS WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT AND NO ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917437 ↗
• MalfunctionAug 18, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22832570 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON FOR TRAUMA OF THE LEFT UPPER LIMB FOLLOWING A FALL FROM A BICYCLE. DURING THE INTERVENTION (HUMERAL OSTEOSYNTHESIS) A DRILL BIT OF THE BROKE IN THE PATIENT. THE PIECES HAVE BEEN RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370346 ↗
• MalfunctionJun 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON NOTICED THAT THE DRILL BIT WAS VERY DULL AND WAS NOT FUNCTIONING ADEQUATELY. THE ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED. THE SURGERY WAS NOT DELAYED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358795 ↗