NA 03.133.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982269621), received between Oct 27, 2020 and Aug 11, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  It was reported that during the procedure, the doctor proceeded to drill the cortex using a 2.5 mm drill bit; the tip snapped while pressure was being applied to drill. The specialist was unable to retrieve this small fragment. The surgery concluded without any further issues or complications. There was no patient harm and no surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216043 ↗
• MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543032 ↗
• MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543016 ↗
• MalfunctionNov 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING LEFT LATERAL TIBIA OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH ALLOGRAFT, WHILE THE SURGEON WAS USING THE DRILL BIT, HOWEVER, THE TIP OF THE DRILL BROKE OFF IN THE BONE. THE SURGEON USED C-ARM TO CONFIRM THE BROKEN PIECE IN BONE. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20603967 ↗
• MalfunctionOct 29, 2024

  DURING LEFT LATERAL TIBIA OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH ALLOGRAFT, WHILE THE SURGEON WAS USING THE DRILL BIT, THE TIP OF THE DRILL BROKE OFF IN THE BONE. SURGEON USED C-ARM TO CONFIRM, BROKEN PIECE IN BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20557191 ↗
• MalfunctionMay 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON APR 22, 2024, THE DRILL BIT BROKE OFF AND THE TIP WAS NOT RETRIEVED. FRAGMENTS WERE LEFT AND THE SURGERY WAS SUCCESSFUL WITH NO DELAY. PATIENT OUTCOME IS REPORTED AS SUCCESSFUL. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353889 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS AND SCREWS BROKE WHILE DRILLING AROUND A FEMORAL PROSTHESIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED; IT IS UNKNOWN WHETHER THEY WERE EASILY REMOVED WITHOUT FURTHER INTERVENTION. THIS REPORT INVOLVES ONE 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804964 ↗
• MalfunctionJun 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 WHILE ATTEMPTING TO DRILL, THE TIP OF A 2.5 DRILL BIT BROKE OFF INSIDE OF THE PATIENT. THE DRILL BIT FRAGMENT WAS SUCCESSFULLY RETRIEVED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES ONE(1) DEVICE 2.5 DRILL BIT QC 170 80 CALIBRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828096 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE TIP OF THE DRILL BIT BROKE OFF DURING INSERTION OF THE UNK - SCREWS: 3.5 MM CORTEX. THE EVENT OCCURRED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT PROXIMAL TIBIA FX. THE SURGEON WAS DRILLING THROUGH THE OBLONG HOLE OF A 3.5MM LCP POSTEROMEDIAL PLATE USING A 2.5MM DRILL BIT WITH THE 3.5MM NON-LOCKING DRILL GUIDE. THE ANGLE OF DIFFICULTY IN RELATION TO WHERE THE PLATE WAS POSITIONED AND HOW THE LEG WAS POSITIONED MADE IT DIFFICULT FOR THE SURGEON TO AIM THE DRILL BIT AT THE CORRECT ANGLE. HE DRILLED THROUGH THE OBLONG HOLE OF THE PLATE AND INTO THE NEAR AND FAR CORTEX WITHOUT COMPLICATION. AS THE SURGEON BACKED OUT AND RETRACTED THE DRILL BIT FROM THE FAR CORTEX, IT WAS NOTICED THAT THE TIP OF THE DRILL BIT WAS MISSING. AN X-RAY OF THE LEFT PROXIMAL TIBIA SHOWED THAT THE TIP OF THE DRILL BIT WAS JUST ANTERIOR OF THE PLATE IN THE OBLONG HOLE OF THE 3.5 MM LCP POSTEROMEDIAL PLATE. THE SURGEON THEN TOOK THE PLATE OFF AND PROCEEDED TO SEARCH FOR THE MISSING TIP OF THE 2.5MM DRILL BIT. AFTER SUCTIONING, SMALL NEEDLE-NOSE CLAMPS WERE USED IN RETRIEVING THE MISSING TIP OF THE 2.5MM DRILL BIT. HE THEN RE-POSITIONED THE 3.5MM LCP POSTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728010 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.5 DRILL BIT QC 170 80 CALIBRATION. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602763 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.5 DRILL BIT QC 170 80 CALIBRATION. THIS REPORT IS 3 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602751 ↗
• MalfunctionOct 27, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE NEW DRILL BITS WERE DULL. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10740650 ↗