NA 310.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10886982186232), received between Feb 10, 2017 and Sep 4, 2026 — classified as 34 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Break” (111 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 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50611444 ↗
• MalfunctionFeb 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PRODUCTS BROKE DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322002 ↗
• MalfunctionAug 15, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SCAPULA FRACTURE WITH THE DRILL BIT. THE DRILL BIT BROKE INSIDE OF THE BODY. THE TIP OF THE FIRST DRILL BIT BROKE INTO PIECE, BUT THE FRAGMENTS HAVE BEEN RETRIEVED. THE TIP OF THE SECOND DRILL BIT ALSO BROKE OFF BY ABOUT 1 MM. THE NURSE SAID IT'S POSSIBLE THAT NOT ALL OF IT COULD HAVE BEEN RETRIEVED. INTRAOPERATIVE IMAGES AND FINAL IMAGE CHECKS SHOWED NO REMAINS INSIDE THE BODY, SO THE WOUND WAS CLOSED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22816778 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SCAPULA FRACTURE WITH THE DRILL BIT. THE DRILL BIT BROKE INSIDE OF THE BODY. THE TIP OF THE FIRST DRILL BIT BROKE INTO PIECE, BUT THE FRAGMENTS HAVE BEEN RETRIEVED. THE TIP OF THE SECOND DRILL BIT ALSO BROKE OFF BY ABOUT 1 MM. THE NURSE SAID IT'S POSSIBLE THAT NOT ALL OF IT COULD HAVE BEEN RETRIEVED. INTRAOPERATIVE IMAGES AND FINAL IMAGE CHECKS SHOWED NO REMAINS INSIDE THE BODY, SO THE WOUND WAS CLOSED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816739 ↗
• MalfunctionAug 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE A 2.0MM DRILL BIT BROKE WHILE DRILLING. A SMALL FRAGMENT OF THIS WAS LEFT INSIDE THE PATIENT'S BONE SINCE IT COULD NOT BE REMOVED DUE TO DIFFICULT EXTRACTION. THEN ANOTHER BIT OF THE SAME DIAMETER AND CHARACTERISTICS WAS USED. IN ADDITION TO THIS WHEN PLACING THE SCREWS A 3.0MM SCREWDRIVER BROKE. ANOTHER SCREWDRIVER FROM THE STOCK WAS THEN USED WITHOUT PROBLEM BECAUSE THE SCREWS TO BE PLACED WERE SELF-DRILLING. THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY, AND WITHOUT ALTERATIONS IN SURGICAL TIMES. DURING AND AFTER THE SURGERY THE PATIENT'S CONDITION WAS STABLE AND WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22777911 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRILL BREAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554705 ↗
• MalfunctionJun 26, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPERATION TO TREAT LEFT PATELLA FRACTURE. SURGEON PLANNED TO INSERT 2 HEADLESS COMPRESSION SCREWS IN PARALLEL MANNER ACROSS FRACTURE SITE. IT WAS DIFFICULT TRAJECTORY. THE FIRST GUIDE WIRE WAS INSERTED WITHOUT ISSUE. SECOND GUIDE WIRE WAS INSERTED IN A CONVERGENT MANNER AND IMPACTED TO THE FIRST GUIDE WIRE, RESULTED IN BREAKAGE OF THE TIP OF THE SECOND GUIDE WIRE WITHIN BONE. SURGEON DECIDED NOT TO REMOVE IT. A CANNULATED DRILL BIT TIP WAS INSERTED OVER THE GUIDE WIRE AND REAMING WAS DONE. HOWEVER, THE TIP WAS BROKEN OFF WITHIN BONE PROBABLY ALSO DUE TO THE DIFFICULT TRAJECTORY. IT WAS ALSO DECIDED NOT TO REMOVE. THE CANNULATED SCREWDRIVER WAS USED TO INSERT THE HEADLESS COMPRESSION SCREW, THE SCREW DRIVER'S TIP BROKE OUTSIDE THE BONE AND WAS ABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22340869 ↗
• MalfunctionJun 26, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF DRILLING, A LACK OF EDGE WAS EVIDENT IN THE EDGES OF THE CANNULATED BITS, GENERATING THIS DISCOMFORT TO THE SPECIALIST. THERE WAS NO WAY TO GIVE A SOLUTION ABOUT IT AND WE HAD TO WORK WITH THESE DRILL BITS WITHOUT EDGES. IT WAS POSSIBLE TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338580 ↗
• MalfunctionJun 26, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF DRILLING, A LACK OF EDGE WAS EVIDENT IN THE EDGES OF THE CANNULATED BITS, GENERATING THIS DISCOMFORT TO THE SPECIALIST. THERE WAS NO WAY TO GIVE A SOLUTION ABOUT IT AND WE HAD TO WORK WITH THESE DRILL BITS WITHOUT EDGES. IT WAS POSSIBLE TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338578 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BIT BROKE WHILE DRILLING INTO THE BONE. A PROMPT SOLUTION WAS FOUND, COMPLETELY REMOVING THE FRAGMENTS OF THIS DRILL BIT AND USING ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS, ALSO INCLUDED WITH THE EQUIPMENT. THIS RESULTED IN A SUCCESSFUL COMPLETION OF THE SURGERY, WITHOUT DISCOMFORT TO THE SPECIALIST, WITHOUT HARMING THE PATIENT, AND WITHOUT ALTERING THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160840 ↗
• MalfunctionMar 5, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT 10 MINUTES AFTER THE INCISION, THE 1ST CANNULATED BIT BREAKS IN THE FRACTURE SITE AS WELL AS THE MARKER ROD. THE INTERNAL RETRIEVES 1 DEBRIS OUT OF THE TOTAL 3 BUT NOT THE PIECE OF ROD. WE'RE DOING A RADIO CHECK TO DETERMINE THE LOCATION OF THE OTHER 2 DEBRIS. THE SURGEON THEN USES THE 2TH BIT WHICH ALSO BREAKS. THE 2 SMALL SHARDS ARE RECOVERED. THE CONTRALATERAL INCISION IS THEN MADE TO RECOVER THE ROD WHICH WAS REMOVED WITH GREAT DIFFICULTY AND NECESSITATING SIGNIFICANT BONE CURETTAGE AND NUMEROUS RADIO CHECKS. THE INTERVENTION LASTED 1 HOURS. THIS INCIDENT OBLIGES THE SURGEON TO CHANGE OSTEOSYNTHESIS TECHNIQUE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21528905 ↗
• MalfunctionFeb 12, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRA-OP EVENT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS. NO FRAGMENTS WERE GENERATED.

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

  MAUDE report 21364223 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED A DRILL BIT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21346012 ↗
• MalfunctionFeb 3, 2025Break; Entrapment of Device; Break; Entrapment of Device

  DURING AN OSTEOSYNTHESIS SURGERY TO IMPLANT A COMPRESSION SCREW, THE TIP OF THE DRILL BIT BROKE OFF OF THE DRILL BIT INTO THE PATIENT. A PIECE OF THE DRILL BIT WAS RECOVERED, BUT DESPITE MULTIPLE ATTEMPTS, ANOTHER PIECE OF THE DRILL BIT WAS NOT RECOVERED AND REMAINED IN THE SOFT TISSUE. ESTIMATED SIZE OF REMAINING FRAGMENT IS 1MM. THERE ARE NO REPORTED PATIENT CONSEQUENCES BUT BUT HEALTH PROFESSIONALS ARE CONCERNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21297117 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL BIT HAD BROKEN DOWN. THIS REPORT IS FOR A 2.0MM CANNULATED DRILL BIT/QC 150MM.

  Patient problems: Insufficient Information

  MAUDE report 20368743 ↗
• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE GUIDE NEEDLE 1.1L150 BECAME TRAPPED IN THE CANNULATED BIT 2/1.15 L150/48 3 EDGES. THERE WAS NO DELAY IN THE PROCEDURE; SURGERY ENDED WITH SUCCESS. THIS REPORT IS FOR A 2.0MM CANNULATED DRILL BIT/QC 150MM.

  Patient problems: Insufficient Information

  MAUDE report 20201272 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 WHILE USING THE GUIDE WIRE WITH ITS CORRESPONDING GUIDE, THE TIP OF THE DRILL BIT BROKE INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PROCEDURE OR PATIENT OUTCOME. THIS REPORT IS FOR ONE DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE F/ THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20086638 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON USED THE 2.0 DRILL BIT OF THE CANNULATED 3.0 HCS SYSTEM. THE DRILL BIT BROKE, AND THE DRILL BIT AND THE FRAGMENT WERE REMOVED FROM THE PATIENT. NOTHING WAS EVIDENT IN THE PATIENT. ANOTHER 2.0 DRILL BIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829078 ↗
• MalfunctionApr 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHEN THE BONE IS BEING DRILLED, THE DRILL BIT BROKE, LEAVING A PART OF THE DRILL BIT IN THE PATIENT, WHICH DOES NOT AFFECT THE PATIENT. AT THE TIME OF FINISHING SCREWING THE FIRST SCREW WHEN THE SPECIALIST HANDED THE SCREWDRIVER IT WAS OBSERVED THAT THERE IS A BREAKDOWN IN THE PAINT. THERE WERE NO COMPLICATIONS IN THE SURGERY AND IT WAS FINISHED WITHOUT DIFFICULTY. THIS REPORT IS FOR ONE (1) 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19047501 ↗
• MalfunctionMar 21, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE 3.0 HCS DRILL BIT HAD BROKEN WHILE DRILLING DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18952234 ↗
• MalfunctionFeb 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE EDGES OF THE DRILL BIT IN QUESTION GOT STUCK INSIDE WITH A GUIDE NEEDLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18731315 ↗
• MalfunctionDec 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF STARTING DRILLING, IT WAS EVIDENT THAT A FRAGMENT WAS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY SINCE IT WAS NOT NECESSARY TO USE THE DRILL AGAIN. THERE WAS NO DELAY IN SURGERY, AND THE FRAGMENT COULD BE REMOVED IMMEDIATELY AND EASILY; THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328992 ↗
• MalfunctionNov 22, 2023Break; Break

  THE ISSUE WAS NOTED POSTOPERATIVELY ON (B)(6) 2023. NO OTHER MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 18193786 ↗
• MalfunctionOct 6, 2023Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DRILL BIT IN QUESTION BROKE. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17885966 ↗
• MalfunctionSep 29, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION WAS FOUND TO HAVE SPLIT WHEN IT WAS REMOVED FROM THE GUIDE. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING ANOTHER DRILL BIT OF THE SAME TYPE. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842664 ↗