NA 03.010.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10886982067319), received between Mar 13, 2017 and Sep 25, 2026 — classified as 9 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902187 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902164 ↗
• MalfunctionSep 22, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862750 ↗
• MalfunctionApr 23, 2026Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURE. IN THE SURGERY, A PROBLEM OCCURRED WHERE THE CUTTING EDGE OF THE DRILL WAS DULL, RESULTING IN EXTENDED OPERATING TIME. DRILLING TOOK LONGER THAN USUAL, ULTIMATELY LEADING TO GET OB FROM A NAIL.THE SURGEON ADDRESSED THE ISSUE BY INSERTING TWO SCREWS DISTALLY USING A K-WIRE OF THE SAME DIAMETER AS THE DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON COMMENTED THAT NO NOTICEABLE SNAGGING WAS DETECTED UPON DIRECT CONTACT WITH THE TIP OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965854 ↗
• MalfunctionApr 23, 2026Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURE. IN THE SURGERY, A PROBLEM OCCURRED WHERE THE CUTTING EDGE OF THE DRILL WAS DULL, RESULTING IN EXTENDED OPERATING TIME. DRILLING TOOK LONGER THAN USUAL, ULTIMATELY LEADING TO GET OB FROM A NAIL. THE SURGEON ADDRESSED THE ISSUE BY INSERTING TWO SCREWS DISTALLY USING A K-WIRE OF THE SAME DIAMETER AS THE DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON COMMENTED THAT NO NOTICEABLE SNAGGING WAS DETECTED UPON DIRECT CONTACT WITH THE TIP OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965853 ↗
• MalfunctionMar 12, 2026Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY. IN THE SURGERY, THE PRODUCT IN QUESTION WAS USED TO DRILL A DISTAL INTERLOCKING SCREW. THE FIRST SCREW WAS DRILLED SUCCESSFULLY, BUT ITS SHARPNESS WAS QUITE DULL. A DIFFERENT DRILL WAS USED TO INSERT THE SECOND SCREW. THIS DRILL WAS BETTER THAN THE FIRST, BUT ITS SHARPNESS WAS STILL QUITE DULL. BOTH SCREWS WERE INSERTED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579676 ↗
• MalfunctionMar 9, 2026Failure to Cut

  IT WAS REPORTED FOR FUNCTIONAL ISSUES DURING AN INTRA-OPERATIVE EVENT. THE DEVICE WAS USED TO DRILL DISTAL INTERLOCKING SCREWS; THE FIRST DRILL WAS NOTED TO BE QUITE DULL, AND A SECOND DRILL, THOUGH BETTER, WAS ALSO DULL. BOTH SCREWS WERE INSERTED SUCCESSFULLY WITHOUT SURGICAL DELAY OR COMPLICATIONS. THE SURGEON EXPRESSED CONCERNS ABOUT THE SHARPNESS OF THE DRILLS, AND THE POTENTIAL RISK OF EXCESSIVE PRESSURE CAUSING HARM, BUT NO PATIENT CONSEQUENCES OR SYMPTOMS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545493 ↗
• MalfunctionMar 9, 2026Failure to Cut

  IT WAS REPORTED FOR FUNCTIONAL ISSUES DURING AN INTRA-OPERATIVE EVENT. THE DEVICE WAS USED TO DRILL DISTAL INTERLOCKING SCREWS; THE FIRST DRILL WAS NOTED TO BE QUITE DULL, AND A SECOND DRILL, THOUGH BETTER, WAS ALSO DULL. BOTH SCREWS WERE INSERTED SUCCESSFULLY WITHOUT SURGICAL DELAY OR COMPLICATIONS. THE SURGEON EXPRESSED CONCERNS ABOUT THE SHARPNESS OF THE DRILLS AND THE POTENTIAL RISK OF EXCESSIVE PRESSURE CAUSING HARM, BUT NO PATIENT CONSEQUENCES OR SYMPTOMS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545488 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT WHEN INSPECTING THE MODULE, TWO BROKEN DRILLS WERE DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979310 ↗
• MalfunctionDec 15, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERAL FRACTURES. WHILE DRILLING FOR DISTAL LOCKING, THE SURGEON NOTED THAT THE DRILL BIT WAS NOT SHARP ENOUGH, BUT THE PROCEDURE ITSELF WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803512 ↗
• MalfunctionDec 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE, WHILE PERFORMING THE DRILLING WITH DRILL BIT, THE TIP BROKE OFF, LEAVING A SMALL FRAGMENT INSIDE THE PATIENT'S BONE. SINCE IT COULD NOT BE REMOVED, THE DOCTOR DECIDED TO LEAVE THIS FRAGMENT IN PLACE DUE TO THE DIFFICULTY OF EXTRACTION AND BECAUSE THERE WOULD BE NO PROBLEM LEAVING IT IN THE BONE. THE REMAINING PORTION OF THE AFOREMENTIONED DRILL BIT WAS THEN REMOVED, AND ANOTHER DRILL BIT OF THE SAME TYPE, ALSO AVAILABLE IN THE KIT, WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAYS. PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23682675 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR HUMERUS SHAFT FRACTURE WITH DRILL BIT AND AWL. DURING SURGERY, IT WAS CONFIRMED THAT THE DRILL BIT BROKE OFF AND THE AWL WAS BENT. IT WAS FURTHER REPORTED THAT THE SURGERY WAS EXTREMELY DIFFICULT AND TOOK APPROXIMATELY FIVE HOURS. THE SURGERY WAS ORIGINALLY SCHEDULED FOR TWO HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772479 ↗
• MalfunctionMay 7, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, AN A-O DRILL TIP HAD BROKEN OFF AND WAS LEFT ABOUT 2 CENTIMETERS INSIDE THE BODY. THE OUTCOME OF THE PATIENT IS CURRENTLY STABLE. THE DOCTORS HAVE STATED THAT THEY WILL CONTINUE TO MONITOR THE SITUATION AND WILL CONSIDER REMOVAL IF NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21978305 ↗
• MalfunctionApr 25, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE ORIF FOR PROXIMAL END HUMERUS FRACTURE WITH THE DRILL. AT THE TIME OF THE DISTAL LOCKING, THE TIP OF THE DRILL WAS INTERFERED WITH THE NAIL. AFTER PASSING THROUGH THE HOLE, TIP OF THE DRILL WAS BROKEN OFF. THE SURGEON SHARPENED OFF THE CORTEX BONE WITH RONGEUR FORCEPS LUER AND REMOVED THE FRAGMENT OF TIP OF THE DRILL. THERE WAS NO FRAGMENT IN THE PATIENT BODY WAS CONFIRMED BY THE SURGEON WITH THE X-RAY. THE SURGEON ASSUMED THE POSSIBLE CAUSE OF THE BREAKAGE WAS THAT THE SURGICAL INCISION WAS SMALL, AND SLEEVE WAS BOUNCED BACK WITH THE SOFT TISSUE. THE SURGEON SHARED THE PERCEPTION THAT IF THE SURGEON LEFT ONE OF DRILL BIT, THAT HELPS PREVENTING INTERFERENCE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHIN 30MINS DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911472 ↗
• MalfunctionApr 25, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911199 ↗
• MalfunctionApr 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIBIAL NAIL EX DRILL BITS ARE REPORTED TO BE DULLING. THERE WERE NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903504 ↗
• MalfunctionApr 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIBIAL NAIL EX DRILL BITS ARE REPORTED TO BE DULLING. THERE WERE NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903460 ↗
• MalfunctionMar 27, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR PROXIMAL HUMERAL FRACTURE. ACCORDING TO THE SURGEON, THE DRILL BIT WAS NOT SHARP ENOUGH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710705 ↗
• MalfunctionMar 27, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR PROXIMAL HUMERAL FRACTURE. ACCORDING TO THE SURGEON, THE DRILL BIT WAS NOT SHARP ENOUGH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710480 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN DRILL BIT 3.2.

  Patient problems: Insufficient Information

  MAUDE report 21642599 ↗
• MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY VIA MULTILOC WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE INTERFERENCE WITH THE NAIL OCCURRED DURING DISTAL LATERAL STOP DRILLING. WHEN THE DRILL TIP LEFT IN THE SLEEVE WAS TAPPED WITH A HAMMER, IT DID NOT PASS THROUGH TO THE MEDIAL CORTEX, SO A 2.0 MM K-WIRE WAS INSERTED NEXT, WHICH PASSED THROUGH THE NAIL TO THE MEDIAL CORTEX. THEN, 2.4 MM TO 3.0 MM DIAMETER K-WIRES WERE USED TO WIDEN THE BONY HOLE. AFTER THAT, A TRANSVERSE STOP SCREW WAS INSERTED, AND THE OPERATION WAS COMPLETED AFTER CONFIRMING THAT THE TRANSVERSE STOP HAD PASSED THROUGH THE NAIL UNDER FLUOROSCOPIC OBSERVATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON AND THE SALES REP CONSIDERED THE POSSIBILITY THAT THE NAIL WAS INTERFERING WITH THE 2.0 MM K-WIRE IN QUESTION THAT WAS TEMPORARILY FIXING THE DISTAL TO PROXIMAL BONE FRAGMENTS WHEN THE NAIL WAS INSERTED, AND THAT THIS K-WIRE WAS LOADING THE NAIL AND DEVICE LIKE A POLAR PIN. IN FACT, AFTER THE TEMPORARY FIXATION K-WIRE WAS REMOVED, THE ABOVE PROCEDURE ALLOWED THE DRILL TO PASS TO THE CONTRALATERAL SIDE. PATIENT OUTCOME IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287633 ↗
• MalfunctionJan 15, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT BREAKAGE OF THE DRILL TIP OCCURRED, RESULTING IN INTRACORPOREAL REMNANTS. THE BROKEN FRAGMENT HAS BEEN LEFT/REMAINED IN THE BODY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21158817 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BITS TIPS BROKEN IN FROM INCORRECT USE DURING A HUMERAL NAILING CASE ON (B)(6) 2024. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20176767 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BITS TIPS BROKEN IN FROM INCORRECT USE DURING A HUMERAL NAILING CASE ON (B)(6) 2024. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20176702 ↗
• MalfunctionAug 22, 2024Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN THE MULTILOC SYSTEM WAS USED FOR THE FIRST TIME TODAY AT THE HOSPITAL. THE DISTAL LOCKING DID NOT WORK PROPERLY BECAUSE THE DRILL DID NOT HIT THE HOLE THROUGH THE AIMING ARM. THIS CAUSED THE DRILL TO BECOME BLUNT. THE SCREW WAS BEING LEFT OUT BY THE SURGEON. THERE WERE NO FRAGMENTS GENERATED. THEREFORE THE DRILL NEEDS TO BE EXCHANGED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038911 ↗