NA 03.130.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982075215), received between Apr 5, 2017 and Mar 25, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break

  IT WAS REPORTED DURING THE PROCEDURE, WHEN THE SPECIALIST MADE THE BROCADE WITH ONE OF THE DRILL BITS FOR CORE HOLE AND FOR THREE-JAW MANDREL, IT BROKE. A PROMPT SOLUTION WAS GIVEN: THE BITS OF THE BIT WERE REMOVED AND A NEW BIT OF THE SAME REFERENCE AND CHARACTERISTICS WAS GIVEN TO DR. WITH THIS BIT IT WAS POSSIBLE TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690923 ↗
• MalfunctionMar 23, 2026Failure to Cut

  IT WAS REPORTED DURING SURGERY, SURGEON COMPLAINED THAT THE IDENTIFIED 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 COMPLAINED SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660338 ↗
• 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 24634709 ↗
• MalfunctionSep 19, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DURING THE PROCEDURE ON (B)(6) 2024, AT THE TIME THE DRILLING, THE DRILL BIT BROKE AND A SMALL FRAGMENT OF IT REMAINED INSIDE THE BONE OF THE PATIENT. THE SURGEON TRIED TO REMOVE THIS SMALL FRAGMENT OF THE DRILL BIT, BUT IT WAS NOT POSSIBLE. THE SURGEON EVALUATED THE AREA WHERE THE FRAGMENT IS LEFT AND DECIDED TO CONTINUE WITH THE PROCEDURE WITH A NEW DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY ADDITIONAL AFFECTATION TO THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES. THE PATIENT'S CONDITION DURING AND AFTER THE SURGERY WAS STABLE AND WITHOUT ADDITIONAL COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20260499 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, WHILE USING THE DRILL BIT TO OPEN A CHANNEL IN THE JOINT, THE DRILL BIT BROKE. FRAGMENTS WERE GENERATED, BUT THESE WERE REMOVED WITHOUT ANY PROBLEM AND THERE WAS NO NEED FOR ADDITIONAL INTERVENTION FOR THE PATIENT. ANOTHER DRILL BIT WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. THIS REPORT IS FOR ONE (1) 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335781 ↗
• MalfunctionAug 23, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6) 2023, THE 1.0 DRILL BIT BROKE. THIS REPORT IS FOR ONE 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17605441 ↗
• InjuryApr 1, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNKNOWN DRILL BIT BROKE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 1.0 DRILL BIT/K-WIRE ATTCHMT THRD H/75. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13976240 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE USING VARIABLE ANGLE HANDSET. DURING THE PROCEDURE, WHILE SURGEON WAS USING A DRILL BIT THROUGH A LOCKING PLATE (VA HANDSET) ON A PROXIMAL PHALANXE, THE DRILL BIT BROKE. THE FRAGMENT WAS REMOVED. THE SURGEON RETRIEVED THE FRAGMENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 1.3 LOCKING PLATE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508520 ↗
• MalfunctionOct 6, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE ON (B)(6) 2020, ONE (1) 1.0MM DRILL BIT WAS BROKEN AND ONE (1) 1.0MM DRILL BIT WAS BENT. NO FRAGMENTS REMAINED IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO OTHER MEDICAL INTERVENTION. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: LOCK STRUT PL 1.3 8HO OBLIQ-ANGL LE L19 (PART # 02.130.159, LOT # L483064, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.0MM DRILL BIT/ K-WIRE ATTCHMT FOR THREADED HOLE/ 75MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638931 ↗
• InjuryMar 14, 2020Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS DRILLING WITH A 1.0 DRILL BIT AND AFTER GOING THROUGH THE FIRST CORTEX, THE DRILL BIT BROKE BEFORE PENETRATING THE SECOND CORTEX. THE TIP OF THE FLUTED DRILL BIT APPROXIMATELY 5 MM WAS RETAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9832889 ↗
• InjuryJan 12, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A THIRD METACARPAL FRACTURE. INTER-OPERATIVE, AS THE SURGEON WAS DRILLING A PILOT HOLE THRU THE 1.3MM LOCKING T -PLATE, THE TIP OF THE 1.0MM DRILL BIT BROKE OFF AND BECAME EMBEDDED IN THE PATIENT¿S METACARPAL BONE. SURGEON THEN ATTEMPTED TO IMPLANT A 1.3MM LOCKING SCREW BUT THE SCREW HEAD BROKE OFF DUE TO THE DISTAL PORTION OF THE SCREW MET THE TIP OF THE PREVIOUSLY EMBEDDED DRILL BIT. THE DISTAL PORTION OF THE 1.3MM LOCKING SCREW REMAINS IN THE PATIENT¿S METACARPAL BONE. SURGEON THEN ATTEMPTED TO DRILL ANOTHER PILOT HOLE, THRU ANOTHER SCREW HOLE POSITION, ON THE LOCKING T-PLATE PLATE BY USING ANOTHER 1.0MM DRILL BIT. AGAIN, THE TIP OF THIS 1.0MM DRILL BIT BROKE OFF AND BECAME IMBEDDED IN THE PATIENT¿S METACARPAL BONE. MOVING FORWARDED ON THE PROCEDURE, SURGEON DECIDED TO REMOVE THE LOCKING T-PLATE. SURGEON SELECTED A 12-HOLE LOCKING PLATE AND SCREWS TO COMPRESS THE FRACTURE. UPON COMPLETING THIS PROCEDURE, THE PATIENT WAS ULTIMATELY IMPLANTED WITH ONE (1) 1.3MM LOCKING 12-HOLE STRAIGHT HOLE PLATE AND A COMBINATION LENGTH OF SIX (6) 1.3MM CORTEX STARDRIVE SCREWS. ADDITIONAL X-RAYS WERE TAKEN TO VE

  Patient problems: Foreign Body In Patient

  MAUDE report 7185893 ↗
• InjuryJan 12, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A THIRD METACARPAL FRACTURE. INTER-OPERATIVE, AS THE SURGEON WAS DRILLING A PILOT HOLE THRU THE 1.3MM LOCKING T -PLATE, THE TIP OF THE 1.0MM DRILL BIT BROKE OFF AND BECAME EMBEDDED IN THE PATIENT¿S METACARPAL BONE. SURGEON THEN ATTEMPTED TO IMPLANT A 1.3MM LOCKING SCREW BUT THE SCREW HEAD BROKE OFF DUE TO THE DISTAL PORTION OF THE SCREW MET THE TIP OF THE PREVIOUSLY EMBEDDED DRILL BIT. THE DISTAL PORTION OF THE 1.3MM LOCKING SCREW REMAINS IN THE PATIENT¿S METACARPAL BONE. SURGEON THEN ATTEMPTED TO DRILL ANOTHER PILOT HOLE, THRU ANOTHER SCREW HOLE POSITION, ON THE LOCKING T-PLATE PLATE BY USING ANOTHER 1.0MM DRILL BIT. AGAIN, THE TIP OF THIS 1.0MM DRILL BIT BROKE OFF AND BECAME IMBEDDED IN THE PATIENT¿S METACARPAL BONE. MOVING FORWARDED ON THE PROCEDURE, SURGEON DECIDED TO REMOVE THE LOCKING T-PLATE. SURGEON SELECTED A 12-HOLE LOCKING PLATE AND SCREWS TO COMPRESS THE FRACTURE. UPON COMPLETING THIS PROCEDURE, THE PATIENT WAS ULTIMATELY IMPLANTED WITH ONE (1) 1.3MM LOCKING 12-HOLE STRAIGHT HOLE PLATE AND A COMBINATION LENGTH OF SIX (6) 1.3MM CORTEX STARDRIVE SCREWS. ADDITIONAL X-RAYS WERE TAKEN TO VE

  Patient problems: Foreign Body In Patient

  MAUDE report 7185843 ↗
• InjuryApr 5, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE FIRST METACARPAL A 1.0 MM DRILL BIT FROM A MODULAR HAND SYSTEM SHEARED OFF INSIDE THE PATIENT¿S FINGER. THE FRAGMENT WAS RETAINED AND WAS UNABLE TO BE REMOVED. X-RAY TAKEN (B)(6) 2017. SURGERY WAS DELAYED 3-5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6460045 ↗