NA 310.284Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886982186416), received between Jul 27, 2017 and Sep 29, 2026 — classified as 5 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935116 ↗
• MalfunctionSep 29, 2026Failure to Cut

  It was reported that during the development of the surgical act, the surgeon requested the set of drill bits to proceed with the bone drilling; however, when he tried to use them, he stated that the supplies lacked the appropriate edge to perform the procedure. Faced with this situation, the specialist said that the drill bits did not have the required conditions and proceeded to bend them with the intention of rendering them useless and expressing his request for replacement of said instruments. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931383 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  IT WAS REPORTED THAT THE LCP DRILL BIT Ø2.8 W/STOP L165 2FLUTE F/ EXPERIENCED A FUNCTIONAL ISSUE DURING A PROCEDURE. THE DRILL BIT WAS FOUND TO BE DULL, WHICH HINDERED THE DRILLING PROCESS AND CAUSED CONSIDERABLE DISCOMFORT TO THE SPECIALIST, PROMPTING AN IMMEDIATE REPLACEMENT WITH ANOTHER BIT OF THE SAME SPECIFICATIONS FROM THE KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EFFECTS OR DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271910 ↗
• MalfunctionFeb 3, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, A DRILL BIT BROKE. THE TIP REMAINED IN THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21297970 ↗
• MalfunctionFeb 15, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE DRILL BITS IN QUESTION WERE NOT CUTTING. IT BECAME NECESSARY TO EXERT GREATER PRESSURE FOR THE DRILL BIT TO ENTER. ADDITIONALLY, THE DRILL BIT WAS BENT DURING DRILLING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710739 ↗
• MalfunctionNov 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS UNDERGOING AN ORIF SURGERY FOR A PROXIMAL HUMERUS FRACTURE. DURING THE PROCEDURE, THE DRILL BIT IN QUESTION BROKE OFF. THE BIT HAD BEEN RUNNING INTO A K-WIRE USED FOR TEMPORARY FIXATION. THE TIP OF THE BROKEN DRILL BIT REMAINED INSIDE OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18129951 ↗
• MalfunctionSep 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION FRACTURED WHILE INSIDE OF THE PATIENT¿S BONE. IT WAS NOT POSSIBLE TO EXTRACT THE FRAGMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17746516 ↗
• MalfunctionAug 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY WITH LCP DRILL BIT. THE SURGEON DRILLED TO INSERT A SCREW-IN-SCREW, BUT THE DRILL BIT BROKE INSIDE A MULTILOC SCREW. THE DRILL BIT WAS REMOVED WITH KOCHEL AND THE SURGERY WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE 2.8MM DRILL BIT/QC/165MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17597690 ↗
• InjuryJul 17, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COSTA RICA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHILE THE SURGEON WAS PLACING A THREAD PLATE, THEY INSERTED THE DRILL BIT IN QUESTION TO PLACE A LOCKED SCREW. THE DRILL BIT BROKE DURING USE BY THE SURGEON, AND THE FRAGMENT REMAINS INSIDE OF THE PATIENT. THE SURGEON DETERMINED NOT TO REMOVE THE BIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17335758 ↗
• MalfunctionFeb 23, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS:IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DRILL BIT IN QUESTION WAS FOUND TO BE BROKEN. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432510 ↗
• InjuryJan 17, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022, THE 2.8 DRILL BIT BROKE. A FRAGMENT REMAINED INSIDE THE PATIENT'S BONE. IN THE CASE OF SYRINGE SYSTEM AND CEMENT, THE NOZZLE DID NOT FIT IN THE T OF THE MIXER AND THE CEMENT HARDENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING REPLACEMENT PRODUCTS OF THE SAME TYPE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16186960 ↗
• InjuryNov 18, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COSTA RICA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INTERNAL FIXATION OF A DISLOCATION OF THE PROXIMAL HUMERUS WAS PERFORMED WITH A PHILOS PLATE. WHEN PLACING THE LOCKED SCREWS OF THE HEAD (ALL WERE PLACED WITH THE RESPECTIVE DRILL GUIDE AND LOCKED IMMEDIATELY) THE DOCTOR INDICATED THAT THE DRILL WAS COLLIDING WITH SOMETHING. X-RAY SHOWED THAT THE DRILL WAS COLLIDING WITH A PIN USED TO REDUCE THE FRACTURE. THE PIN WAS REMOVED AND AN ATTEMPT WAS MADE TO DRILL AGAIN THROUGH THE SAME HOLE, BUT THIS TIME THE BIT BROKE. A FRAGMENT WAS GENERATED, LEAVING THE TIP OF THE DRILL BIT EMBEDDED IN THE PATIENT¿S BONE THAT COULD NOT BE REMOVED. THE REST OF THE SURGERY CONTINUED WITH NO ADVERSE EVENTS, AND WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15825859 ↗
• MalfunctionSep 6, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS FOUND TO BE DULL. THE SURGERY COMPLETED SUCCESSFULLY, THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365745 ↗
• MalfunctionJul 29, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE TIP OF THE DRILL BIT IN QUESTION BROKE. NO FRAGMENTS WERE GENERATED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOMES. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130807 ↗
• MalfunctionJul 29, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION SPLIT. THERE WERE NO FRAGMENTS GENERATED AND THE PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130537 ↗
• MalfunctionJun 14, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, IT WAS DISCOVERED THAT THE DRILL BITS ARE DULL. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687465 ↗
• MalfunctionApr 20, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, TWO DRILL BITS WERE DULL, DETERIORATED, AND BENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A 2.8MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694053 ↗
• MalfunctionApr 20, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLUMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, TWO DRILL BITS WERE DULL, DETERIORATED, AND BENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A 2.8MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693907 ↗
• MalfunctionMar 31, 2021Break; Break

  FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598928 ↗
• InjuryAug 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION OF FRACTURE IN THE RIGHT PROXIMAL TIBIA THAT WHILE DRILLING THE CORTEX, THE DRILL BROKE LEAVING THE REST INSIDE THE BONE OF THE PATIENT. IT COULD NOT BE REMOVED BECAUSE OF THE DIFFICULTY IN THE ANATOMY WITHOUT LEAVING COMPLICATIONS IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN DRILL SLEEVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Foreign Body In Patient; No Code Available

  MAUDE report 10369282 ↗
• InjuryNov 14, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, A DRILL BIT BROKE OFF IN THE PATIENT. THE FRAGMENT REMAINS THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.8 MM DRILL BIT / QC / 165 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9323897 ↗
• MalfunctionMar 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, WHEN PIERCING THE BONE USING THE DRILL BIT QUICK COUPLING, IT BROKE INTO TWO PARTS. THERE WERE FRAGMENTS GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448583 ↗
• MalfunctionJul 30, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, DURING THE DRILLING, THE 2.8MM DRILL BIT WAS BROKEN AND THE FRAGMENT WAS RECOVERED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR A 2.8MM DRILL BIT/QC/165MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732478 ↗
• MalfunctionJul 28, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A DRILL BIT WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL TIP WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751332 ↗
• MalfunctionJul 27, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR DRILL BIT WHICH REPORTEDLY DID NOT FIT WITH OTHER PARTS. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL TIP WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6747949 ↗