NA 03.130.225Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982075406), received between Aug 17, 2018 and Sep 9, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696867 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DRILL GUIDE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700049 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DRILL GUIDE SNAPPED. THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT ANY SURGERY DELAYED DUE TO THE REPORTED EVENT. THE FRAGMENTS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THERE WAS NO OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461419 ↗
• MalfunctionFeb 13, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICES REPROCESSING STAFF IDENTIFIED THAT THE 1.1MM CYLINDRICAL CANNULATION WHERE THE DRILL BIT WOULD PASS THROUGH ON COMPLAINED ITEM, IT WAS BENT AND WOULD NO LONGER ALLOW THE 1.1MM DRILL BIT TO PASS THROUGH. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL, AND WAS SUBSEQUENTLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331411 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THESE ITEMS WERE NOT WORKING PROPERLY. DRILL GUIDES AND T6 POWER SHAFT WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162388 ↗
• MalfunctionOct 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THE ITEMS WERE BENT AT THE START OF THE SURGERY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371318 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED THAT ON APRIL 24, 2024, THE THEATRE TRAY STORE MANAGER WAS NOTIFIED THAT THE VA HAND TRAY'S 1.1MM DRILL END WAS BROKEN. THIS REPORT INVOLVES ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19361310 ↗
• MalfunctionApr 2, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A LOAN KIT INSPECTION IT WAS IDENTIFIED THAT TIP OF THE DOUBLE DRILL SLEEVE IS BENT. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19024113 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE DRILL BIT IN QUESTION BROKE DURING SURGERY. ADDITIONALLY, THE DOUBLE DRILL GUIDE DID NOT FIT. THERE WAS DISCOMFORT FROM THE SPECIALIST AS THE GUIDE DID NOT FIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING ANOTHER DRILL GUIDE AND DRILL BIT OF THE SAME TYPE. THERE WAS NO INVOLVEMENT OF THE PATIENT, THE SPECIALIST MANAGED TO TAKE OUT THE FRAGMENT OF THE DRILL BIT AND USED THE FIXED SIDE OF THE DOUBLE DRILL BIT OF 1.5, THE SURGERY WAS SUCCESSFULLY PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777266 ↗
• MalfunctionJan 3, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MONDAY ,DECEMBER 11, AT 9:30 AM. PART: (REMOVED PRODUCT CODE), 1.5/1.1 DBL DRILL GUIDE FROM VA LOCKING MODULAR SET. IT HAPPENED AT THE HOSPITAL. WE HAD A DRILL BIT THAT GOT STUCK IN THE MIDDLE OF THE CASE. NOT SURE IF THE DRILL BIT WAS BENT. IT SNAPPED IN HALF IN THE GUIDE AND RETAINED IN THE DRILL GUIDE. I'M NOT SURE IF DRILL BIT WAS SLIGHTLY BENT. THERE WERE NO PIECES IN THE PATIENT, SO DID NOT EFFECT THE PATIENT. IT DID NOT DELAY IN THE PROCEDURE BUT THIS NEEDED TO BE REPORTED. THERE IS NO OTHER ADDITIONAL INFORMATION AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5/1.1 DBL DRILL SLV 1.5 CORTEX SCR/RED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436533 ↗
• MalfunctionDec 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE 1.1MM/1.5MM DRILL SLEEVE WAS BENT. THERE WERE NO PATIENT OUTCOMES REPORTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5/1.1 DBL DRILL SLV 1.5 CORTEX SCR/RED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986245 ↗
• MalfunctionOct 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHEN THE DRILL SLEEVE WAS DELIVERED TO THE HOSPITAL, IT WAS CONFIRMED THAT THE DRILL SLEEVE WAS DEFORMED. ON (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH THE DOUBLE DRILL SLEEVE FOR A METACARPAL FRACTURE. BECAUSE THE DRILL SLEEVE WAS DEFORMED, THE SURGEON USED A VA SLEEVE INSTEAD OF THE DRILL SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679368 ↗
• MalfunctionOct 3, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 THE 1.1 GUIDE UPON OPENING SET WAS FOUND BENT AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT GUIDE. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THERE WAS NO GENERATION OF FRAGMENTS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 1.5/1.1 DBL DRILL SLV 1.5 CORTEX SCR/RED. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15529574 ↗
• MalfunctionJul 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 DRILL GUIDE WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958311 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DRILL GUIDE WAS UNABLE TO BE STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653503 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, THE DRILL SLEEVE WAS BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804058 ↗
• MalfunctionOct 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, WHILE RESTOCKING AND CLEANING, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS WERE BROKEN. ONE (1) REDUCTION FORCEPS WITH THE SERRATED JAW, RATCHET, ONE (1)REDUCTION FORCEPS WITH POINTS, NARROW RATCHET, ONE (1) 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601660 ↗
• MalfunctionJun 7, 2021Material Twisted/Bent; Material Twisted/Bent

  THE VISUAL INSPECTION OF THE RECEIVED DEVICE SHOWED THAT THE 1.1 MM DRILL SLEEVE COMPONENT WAS BENT AND RED COLOR EPOXY MARKING WAS MISSING ON ONE SIDE. ADDITIONALLY, SCRATCHES AND NICKS WERE OBSERVED ON THE DEVICE. NO OTHER VISUAL DAMAGES WERE OBSERVED ON THE DEVICE. THIS REPORT IS FOR A DRILL SLEEVE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946918 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SURGICAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. THE DRILL GUIDE BROKE, CUTTER DOESN¿T WORK, AND T4 SHAFT IS BENT AT THE HEAD. IT IS UNKNOWN THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT THERE WAS A SURGICAL DELAY AND NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 1.5MM VAL STRAIGHT PLATE 12 HOLES (PART# 02.130.251; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856567 ↗
• MalfunctionMar 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON FEB 9, 2021 DURING AN UNKNOWN PROCEDURE, THE DOUBLE DRILL SLEEVE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438235 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREW IS BENT AND A STARDRIVE SCREWDRIVER SHAFT TIP IS TWISTED. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113877 ↗
• MalfunctionDec 31, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE DOUBLE DRILL SLEEVE BROKE DURING SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102105 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE ITEMS WERE INVOLVED. ONE 1.5/1.1 DRILL GUIDE BROKE, ONE 2.7/2.0 DRILL GUIDE WAS BROKEN WITH A DRILL BIT COLD WELDED INTO IT, AND A CRUCIFORM SCREWDRIVER HEAD WAS STRIPPED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE STATUS WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029196 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FEMUR PROCEDURE, THE 2 DEPTH GAUGE BROKE, 2 RATCHETING SCREWDRIVER HANDLE AND 2 CANNULATED SCREWDRIVER HANDLE WITH RATCHET QUICK COUPLING HAD STOPPED RATCHETING, 1 DOUBLE DRILL SLEEVE HAD BROKEN OFF SOFT TISSUE GUIDE, AND 2 STARDRIVE SCREWDRIVER SHAFT HAD STRIPPED HEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET. THERE WAS A 5 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10781094 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2020, A DOUBLE DRILL GUIDE WAS FOUND TO BE BENT. THE DOUBLE DRILL GUIDE WILL NOT GO DOWN THE TUBE. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521781 ↗