NA 310.19Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982186102), received between Aug 18, 2017 and Dec 10, 2024 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Failure to Cut; Scratched Material; Failure to Cut; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT THE INSTRUMENT WAS DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895615 ↗
• MalfunctionDec 6, 2024Failure to Cut; Scratched Material; Failure to Cut; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT SEVERAL OF THE INSTRUMENTS WERE DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872150 ↗
• MalfunctionDec 6, 2024Failure to Cut; Scratched Material; Failure to Cut; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT SEVERAL OF THE INSTRUMENTS WERE DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871155 ↗
• MalfunctionDec 6, 2024Failure to Cut; Scratched Material; Failure to Cut; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT SEVERAL OF THE INSTRUMENTS WERE DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870025 ↗
• MalfunctionMar 18, 2024Break; Entrapment of Device; Activation, Positioning or Separation Problem; Material Integrity Problem; Break; Entrapment of Device; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BROKEN DRILL LEFT IN THE PATIENTS HIP. THIS REPORT IS FOR ONE (1) UNKNOWN DRILL BITS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18924597 ↗
• InjuryJul 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A DRILL 2.0MM BIT, BROKE INTRAOPERATIVELY INSIDE PATIENT. PART OF THE DRILL BIT WAS REMOVED AND THE FAR SHAFT OF THE BIT WAS RETAINED INSIDE PATIENT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 2.0MM DRILL BIT/QC/100MM FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17405016 ↗
• MalfunctionNov 29, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN SURGERY, THE DRILL BIT BROKE. THE DRILL WAS USED AS A ROTATIONAL REFERENCE MARKER. THE SURGEON TRIED PASSING A FLEXIBLE REAMER PAST. THE DRILL BIT BROKE INTO TWO SEGMENTS WHEN THE REAMER ENGAGED. BOTH SEGMENTS WERE RETRIEVED. AND, REAMING ROD PUSHER WAS STUCK WHEN USED TO CLEAR OUT BONE FROM A CANNULATED DRILL. THE ROD PUSHER WAS PULLED OUT WITH FORCE, REVEALING A BENT WIRE SHAFT. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882708 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1)2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 2 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410611 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1)2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 1 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410539 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THIRTY (30) DEVICES. THIS REPORT IS FOR (1)2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 20 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389134 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 19 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389130 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 4 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388755 ↗
• MalfunctionJun 7, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948894 ↗
• MalfunctionJun 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES 1 DEVICES. THIS REPORT IS FOR 1 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942608 ↗
• MalfunctionJun 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES 6 DEVICES. THIS REPORT IS FOR 1 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942602 ↗
• MalfunctionJun 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES 6 DEVICES. THIS REPORT IS FOR 1 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942594 ↗
• MalfunctionJun 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942593 ↗
• MalfunctionJun 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942578 ↗
• MalfunctionFeb 21, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OF THE PROXIMAL HUMERUS ON (B)(6) 2020, THE 2.0MM DRILL BIT BROKE. THERE WERE FRAGMENTS GENERATED WHICH WERE SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9740619 ↗
• InjuryAug 27, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ORTHOPEDIC PROCEDURE, THE DRILL BIT WAS BROKEN AND UNABLE TO BE RETRIEVED. FRAGMENTS WERE GENERATED AND LEFT INSIDE THE PATIENT AND NO MEDICAL INTERVENTION WAS MADE. NO PLANS TO REMOVE THE FRAGMENTS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT WAS FINE AND DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8937193 ↗
• InjuryAug 18, 2017Break; Material Fragmentation; Break; Material Fragmentation

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED THAT A 2.0 MM DRILL BIT/QUICK COUPLING/100 MM BROKE DURING A TISSUE GRAFTING OF THE PATELLA ON (B)(6) 2017. THE TIP OF THE DRILL BIT BROKE OFF IN THE PATELLA AND WAS LEFT IN THE PATIENT. SURGICAL DELAY AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.0 MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6805681 ↗