NA 03.130.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10886982075338), received between May 8, 2017 and Jun 19, 2026 — classified as 29 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Break” (110 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 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Break

  IT WAS REPORTED THE DRILL BIT BROKE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565654 ↗
• MalfunctionJun 18, 2026Break; Entrapment of Device

  DURING SURGERY, THE DRILL BIT BROKE, LEAVING PART OF IT IN THE PATIENT'S BONE. NO ATTEMPT WAS MADE TO REMOVE IT BECAUSE IT WAS NOT VISIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25548095 ↗
• MalfunctionMay 15, 2026Break; Entrapment of Device

  DURING THE PROCEDURE, WHILE THE DOCTOR WAS DRILLING THE HOLES IN THE BONE USING THE 1.1 MM DRILL BIT FROM THE 1.5 MM SYSTEM, THE TIP OF THE DRILL BIT BROKE OFF, LEAVING A SMALL FRAGMENT INSIDE THE PATIENT'S BONE. THE DOCTOR ATTEMPTED TO REMOVE THE FRAGMENT BUT WAS UNABLE TO DO SO. HE DECIDED TO LEAVE IT IN PLACE DUE TO THE DIFFICULTY OF EXTRACTION AND BECAUSE IT WAS NOT INSIDE THE JOINT. THE REMAINING PORTION OF THE DRILL BIT WAS THEN REMOVED, AND ANOTHER DRILL BIT OF THE SAME TYPE, ALSO INCLUDED IN THE KIT, WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY CHANGES TO THE SURGICAL SCHEDULE OR DISCOMFORT FOR THE SPECIALIST.

  Patient problems: Foreign Body In Patient

  MAUDE report 25187599 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A DRILL BIT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149496 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SPECIALIST USED THE Ø 1.1 MM BIT, IT WAS BROKEN DURING DRILLING. THE FRAGMENTS OF THE BROKEN BIT WERE REMOVED, AND THE SPECIALIST WAS PROVIDED WITH ANOTHER BIT OF IDENTICAL SPECIFICATIONS, WHICH WAS ALSO AVAILABLE IN THE SURGICAL KIT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT AND WITHOUT ANY DISRUPTION TO THE SURGICAL TIMELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008262 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE NURSE BROKE THE DRILL BIT IN QUESTION WHEN OPENING THE PRODUCT FROM THE PACKAGE, RENDERING IT UNUSABLE. THE OPERATION WAS HALTED FOR ABOUT 10 MINUTES TO RETRIEVE ANOTHER DRILL BIT FROM STOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884713 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, A 1.1 MM BIT WAS BROKEN AND THE TIP OF THE PATIENT¿S BIT WAS EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815539 ↗
• MalfunctionMar 30, 2026Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE HANDPIECE TAKES TIME TO COME TO A STOP AFTER BEING ACTIVATED. THE BURS WERE DULL, WHICH CAUSED THEM TO OVERHEAT AND FRACTURE, LEAVING FRAGMENTS INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24716587 ↗
• MalfunctionMar 30, 2026Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE HANDPIECE TAKES TIME TO COME TO A STOP AFTER BEING ACTIVATED. THE BURS WERE DULL, WHICH CAUSED THEM TO OVERHEAT AND FRACTURE, LEAVING FRAGMENTS INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24716583 ↗
• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698277 ↗
• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698276 ↗
• MalfunctionMar 18, 2026Failure to Cut

  DURING SURGERY, IT WAS NOTED THAT THE IDENTIFIED DRILL BITS LISTED IN THIS COMPLAINT WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627473 ↗
• MalfunctionMar 9, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DRILL BIT Ø1.1 L56/39 F/CORE HOLE WAS BROKEN DURING A SURGICAL PROCEDURE, RESULTING IN THE TIP OF THE DRILL BIT REMAINING EMBEDDED WITHIN THE PATIENT'S BONE. THE FRAGMENT COULD NOT BE REMOVED DUE TO THE DIFFICULTY OF EXTRACTION, AND THE DECISION WAS MADE TO LEAVE IT IN PLACE AS IT WAS NOT EXPECTED TO CAUSE ANY ISSUES. THE EXCESS PORTION OF THE DRILL BIT WAS REMOVED, AND ANOTHER DRILL BIT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT ANY ALTERATION IN SURGICAL TIMES OR REPORTED DISCOMFORT TO THE SPECIALIST.

  Patient problems: Foreign Body In Patient

  MAUDE report 24545135 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A 1.1MM DRILL BIT WAS FOUND BROKEN AFTER SURGERY AT HOSPITAL ON (B)(6) 2026. THE DRILL BIT HAD BEEN INSERTED INTO THE PATIENT AND IT REMAINS UNCONFIRMED WHETHER THE FRACTURED PORTION REMAINED INSIDE THE PATIENT. THE OPERATION WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24324598 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, A1.1 MM DRILL BIT BROKE WHILE DRILLING THE FINAL HOLE IN THE BONE. THIS ISSUE WAS IMMEDIATELY RESOLVED BY REMOVING THE DRILL BIT ALONG WITH THE FRAGMENT, AND THE DOCTOR WAS GIVEN ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS. WITH THIS NEW BIT, THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS INCIDENT CAUSED NO DISCOMFORT FOR THE SPECIALIST, NO ADVERSE EFFECTS ON THE PATIENT, AND NO ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212378 ↗
• MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE DRILLING, THE TIP OF THE 1.1 DRILL BIT/MQC FOR THREADED HOLE/56 BROKE, LEAVING A FRAGMENT EMBEDDED IN THE PATIENT'S METACARPAL BONE. THE DOCTOR ATTEMPTED TO REMOVE THE FRAGMENT BUT WAS UNSUCCESSFUL. DUE TO THE DIFFICULTY OF EXTRACTION, HE DECIDED TO LEAVE THE TIP IN PLACE, STATING THAT SINCE IT WAS EMBEDDED IN THE BONE, IT WOULD NOT AFFECT THE PATIENT AND WOULD NOT CAUSE ANY PROBLEMS. THE REST OF THE BROKEN DRILL BIT WAS THEN REMOVED, AND ANOTHER DRILL BIT WITH THE SAME SPECIFICATIONS, ALSO INCLUDED IN THE SURGICAL KIT, WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT CONSEQUENCE OR ALTERATION IN SURGICAL TIMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 23923296 ↗
• MalfunctionDec 23, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE AT THE TIME WHEN THE DOCTOR WAS PERFORMING THE BROCADE THE BIT BROKE LEAVING THE TIP OF IT INSIDE THE BONE OF THE PATIENT. THE DOCTOR TRIES TO REMOVE THIS FRAGMENT BUT IT WAS NOT POSSIBLE AND DECIDED TO LEAVE THIS TIP BECAUSE OF THE DIFFICULT EXTRACTION. ANOTHER BIT WAS USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23877282 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN DRILL BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714652 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BITS BROKE WHEN DRILLING, ONE REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057893 ↗
• MalfunctionSep 15, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DRILL BITS BROKE WHEN DRILLING, ONE REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23057874 ↗
• MalfunctionSep 9, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PLATES. DURING DRILLING, THE DRILL BIT BROKE OFF, AND THE BROKEN DRILL BIT REMAINED INSIDE THE BODY. THE SURGEON COMMENTED THAT THE DRILL BIT MIGHT HAVE INTERFERED WITH A SCREW AND HAVE BROKEN OFF SINCE THE SURGEON HAD THE PLATES BENT. THE SURGEON ALSO COMMENTED THAT HE/SHE BELIEVED THE EVENT WAS CAUSED BY INTERFERENCE WITH THE SCREW AND THEREFORE THERE WAS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003407 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE A BROKEN DRILL BIT AND ITS REMOVED. (B)(4) SYN OPCO WAS CREATED FOR ANOTHER ADDITIONAL IMPACTED PRODUCT (B)(4) WAS CREATED FOR PRODUCTS 03.130.010 AND 03.130.202. (B)(4) PTS OPCO FOR PRODUCT 05.001.120.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912473 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY 45 DEGREES CANC / 3 JAW ADAPTER DID NOT WORK WHEN USED WITH THE ENGINE AIR PEN ELECTRIC. SURGEON THEN USED QUICK ANCHOR ADAPTER. ADDITIONALLY 1.1 L 56/39 DRILL BOT BROKE WHILE DRILLING. THE BROKEN FRAGMENTS WERE REMOVED AND ANOTHER 1.1 L 56/39 DRILL BIT WAS USED WITH WHICH IT WAS POSSIBLE TO WORK DURING THE PROCEDURE EVIDENCING THAT IT HAD VERY LITTLE EDGE BECAUSE IT DID NOT CUT VERY MUCH WELL, IN TURN IT HAPPENED THAT WHEN TRYING TO PLACE THE SCREWS WITH THE 1.3/.1.5 T4 SELF-LOCKING SCREWDRIVER, IT DID NOT WORK CORRECTLY BECAUSE IT DID NOT HOLD THE SCREWS AS ITS TIP WAS WORN. THIS ISSUE WAS RESOLVED BY CHANGING THE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904361 ↗
• MalfunctionAug 8, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF MAKING THE BROCADE, THE DRILL BIT WAS BROKEN, LEAVING A SMALL FRAGMENT OF THIS INSIDE THE PATIENT'S BONE SINCE IT COULD NOT BE REMOVED AND THE SURGEON DECIDED TO LEAVE THIS FRAGMENT BECAUSE OF THE DIFFICULT EXTRACTION. THIS PROBLEM WAS THEN RESOLVED BY PASSING ANOTHER BIT OF THE SAME DIAMETER AND OF THE SAME CHARACTERISTICS THAT ALSO COMES WITHIN THE EQUIPMENT, THUS ACHIEVING TO FINISH THE SURGERY SUCCESSFULLY, WITHOUT DISCOMFORT OF THE SPECIALIST, AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 22750164 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT AS INDICATED BY INSTRUMENTATOR, A HAND PIECE OF THE INSTITUTION WAS USED, APPARENTLY IT HAS A LOT OF POWER AND THE BITS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644717 ↗