NA 03.133.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982269959), received between Dec 11, 2019 and Feb 3, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break; Material Deformation

  IT WAS REPORTED THAT THE 2.0 SIDE OF TISSUE PROTECTION SLEEVE IS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250221 ↗
• MalfunctionJan 26, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT 2.0 SIDE BROKEN, NOT LETTING 2.0 DRILL THROUGH. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183170 ↗
• MalfunctionSep 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954643 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON¿T CONNECT ON QC. THERE WAS NO PATIENT STATUS CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633553 ↗
• MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON'T CONNECT ON QC. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620835 ↗
• MalfunctionMar 7, 2025Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT ON 10-FEBRUARY-2024, THERE WAS AN INSTRUMENT DEFECT. THE PLASTIC WAS BROKEN. ADDITIONALLY, THE COLOR CODING WAS NOT COMPLETE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549185 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN DRILL GUIDE. THERE WAS NO PATIENT STATUS, OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161690 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN DRILL GUIDE. THERE WAS NO PATIENT STATUS, OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161449 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160269 ↗
• MalfunctionSep 4, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, A DRILL WAS JAMMED INTO THE DRILL GUIDE. THEY WANTED TO IMPLANT A 2.7 LAG SCREW, SO HE TOOK ON A 2.7 NON-LOCKING DRILL GUIDE PLACED OVER A 2.7 DRILL. HE TRIED TO ADVANCE/RETRACT THE DRILL IN AN ATTEMPT TO DISLODGE IT BUT WAS UNSUCCESSFUL AND THE SLEEVE PART OF THE DRILL GUIDE WAS ALSO DAMAGED. THEY OPENED A NEW SET AND USED THE DRILL GUIDE FROM THAT ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWO TO THREE MINUTE DELAY AND NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138485 ↗
• MalfunctionJan 22, 2024Material Deformation; Material Deformation

  THE NAIL REMOVAL SURGERY WAS BEING PERFORMED DUE TO A NON-UNION. THE HAMMER GUIDE THREADED INTO EXTRACTOR AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557160 ↗
• MalfunctionDec 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ONE OF THE DRILL SLEEVES WAS BENT. THE SURGICAL DELAY WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 2.7MM NON-LOCKING DRILL GUIDE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18420862 ↗
• MalfunctionSep 25, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE TWO BROKEN INSTRUMENTS. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17807577 ↗
• MalfunctionAug 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, A USF (UNIVERSAL SMALL FRAGMENT) WAS OPENED FOR AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE, HOWEVER THE SURGEON ENDED UP USING A TENS (TITANIUM ELASTIC NAIL) AND DID NOT USE THE USF. THE NURSES DID NOT RECALL THE DRILL GUIDE BEING BROKEN WHEN THEY OPENED IT. THERE WAS NO PATIENT CONSEQUENCE, AND NO DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571589 ↗
• MalfunctionMar 21, 2023Break; Scratched Material; Break; Scratched Material

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR RIGHT CLAVICULAR SHAFT FRACTURE. BEFORE SURGERY, ON (B)(6) 2023, CHIP-LIKE METAL FRAGMENTS CAME OUT OF THE DRILL GUIDE DURING THE WASHING STAGE. THE SALES REP SECURED THE DRILL GUIDE IN QUESTION BEFORE IT USED IN THE SURGERY. THERE WERE SPIRAL SCRATCHES INSIDE THE DRILL GUIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME? STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) NON-LOCKING DRILL GUIDE 2.7 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583472 ↗
• MalfunctionNov 7, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGEON USED THE DRILL GUIDE FOR AN ITEM TOO LARGE FOR THE GUIDE, AND THE ITEM BECAME STUCK AND BROKE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743169 ↗
• MalfunctionOct 1, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE KIT WAS OPENED DURING SURGERY, AND WHILE DRILLING, THE END BECAME BENT. THERE WAS UNEXPECTED WEAR AS THIS WAS A RELATIVELY NEW SET. THIS REPORT INVOLVES ONE 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523979 ↗
• MalfunctionSep 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT OSTEOSYNTHESIS FOR OBLIQUE FRACTURE OF CLAVICLE. DURING A PROCEDURE, THE 2.7MM DRILL BIT BECAME STUCK IN THE 2.7MM DRILL GUIDE AND COULD NOT BE DETACHED AFTER DRILLING. THE SURGEON THEN DRILLED USING A 2.0MM DRILL BIT WITH ANOTHER DRILL GUIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427228 ↗
• MalfunctionDec 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) CALCANEUS CASE ON AN UNKNOWN DATE, A 2.0MM DRILL GUIDE TIP OF THE 2.0/2.7MM DRILL GUIDE BENT WHILE INSERTING A 1.6MM K-WIRE. THE DRILL GUIDE WAS USED TO PROTECT TISSUE. A DIFFERENT DRILL GUIDE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: K-WIRE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A 2.7MM NON-LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450804 ↗