NA 395.921Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982200921), received between Sep 10, 2018 and Mar 3, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE DOES NOT PASS SMOOTHLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498218 ↗
• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2025, THE PATIENT UNDERWENT AN EXTERNAL SKELETAL FIXATION FOR A DISLOCATION FRACTURE OF THE ANKLE JOINT. WHEN THE SELDRILL WAS INSERTED VIA THE DRILL SLEEVE, THE THREADED PART OF THE SELDRILL GOT STUCK/JAMMED INSIDE THE DRILL SLEEVE JUST AFTER IT WENT THROUGH THE DRILL SLEEVE. THEREFORE, ANOTHER SELDRILL AND A SPARE DRILL SLEEVE WITH THE SAME PRODUCT CODE WERE USED IN THE SURGERY. THE JAMMED SELDRILL AND DRILL SLEEVE WERE MANAGED TO BE SEPARATED AFTER SURGERY, AND IT WAS FOUND THAT THE SHAFT OF THE SELDRILL WAS CLEARLY THICKER THAN THE DRILL SLEEVE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES¿ DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073522 ↗
• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696002 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 21, 2023, THE PATIENT UNDERWENT A TEMPORARY EXTERNAL FIXATION FOR AN ANKLE FRACTURE. WHILE DRILLING THE TIBIAL USING THE SELDRILL WITH THE SLEEVE, THE SELDRILL STOPPED ADVANCING. SINCE THE INSERTION DEPTH WAS SHALLOW, THE SELDRILL AND SLEEVE WERE ABLE TO BE REMOVED, AND THE SURGEON CONTINUED THE OPERATION WITHOUT USING A SLEEVE. THE SELDRILL AND SLEEVE GOT STUCK AND COULD NOT BE DETACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17903959 ↗
• MalfunctionSep 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE IT WAS NOTICED THAT THE SCHANZ SCREW GOT STUCK IN DRILL SLEEVE AND COULD NOT BE REMOVED. SCREW AND SLEEVE WERE REMOVED FROM PATIENT AND ANOTHER SCREW WAS USED TO REPLACE IT. THERE WAS SURGICAL DELAY OF TWO (2) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470420 ↗
• MalfunctionFeb 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION AND EXTERNAL FIXATION FOR TIBIA WITH THE DRILL SLEEVE AND THE SELDRILL. DURING THE SURGERY, THE SURGEON INSERTED THE SELLDRILL TO THE DRILL SLEEVE, AND THEY BECAME FIXED AND STUCK. THE SURGEON USED ANOTHER SELLDRILL OF SAME PRODUCT NUMBER WITH OTHER DRILL SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE DRILLSL 6/5 SHORT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549556 ↗
• MalfunctionMar 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TEMPORARY EXTERNAL FIXATION SURGERY WITH THE SELF-DRILLING SCREW AND SLEEVE. WHEN INSERTING THE SELF-DRILLING SCREW, IT WAS CAUGHT IN THE DRILL SLEEVE AND COULD NOT BE INSERTED. THE SELF-DRILLING SCREW WAS INSERTED WITHOUT USING A SLEEVE, AND THERE WAS NO PROBLEM WITH THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563546 ↗
• MalfunctionMar 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TIBIAL FRACTURE. DURING THE SURGERY, THE SELDRILL STUCK INTO THE SLEEVE. THE SURGEON USED ANOTHER SELDRILL AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) DRILLSL 6/5 SHORT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11465539 ↗
• MalfunctionJan 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE TIBIAL FRACTURE WITH THE SELDRILL AND SLEEVE. DURING THE SELDRILL INSERTION THROUGH THE SLEEVE, THE SELDRILL STUCK TO THE SLEEVE. THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: SELDRILL-SCHANZSCR Ø5 L175/60 TI (PART NUMBER 494.785S, LOT 7L19305, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250897 ↗
• MalfunctionDec 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY WITH THE SLEEVE AND 2SELDRILLS. DURING THE SURGERY, WHEN THE SURGEON INSERTED THE SELDRILL WITH THE 3 CM SLEEVE, THE SELDRILL STUCK INTO THE SLEEVE DUE TO THE BONE WASTE. THE SURGEON WAS ABLE TO DISCONNECT THE SELDRILL FROM THE SLEEVE AND ATTEMPTED TO CONNECT A SECOND SELDRILL TO THE SLEEVE. THE SECOND SELDRILL STUCK INTO THE SLEEVE. THE SURGEON DISCONNECTED THE SLEEVE AND REMOVED THE SLEEVE AND SELDRILL FROM THE PATIENT¿S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS THIRTY (30) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SELDRILL-SCHANZSCR Ø5 L175/60 TI (PART NUMBER 494.785S, LOT 6L97621, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096584 ↗
• MalfunctionNov 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE STEREO-ARTHROLYSIS SURGERY FOR THE ELBOW. DURING THE SURGERY, THE SEL-DRILL WAS STUCK TO THE SLEEVE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854332 ↗
• MalfunctionOct 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE AND UNKNOWN PROCEDURE THAT IT WAS DIFFICULT TO INSERT PIN. IT WAS UNKNOWN WHEN IT¿S OCCURRED. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616772 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, 6 MM/ 5 MM SLEEVES DISTAL OUTSIDE DIAMETER WAS FOUND TO BE TOO LARGE AND WERE FOUND TO NOT SLIDE THROUGH CORRESPONDING 8 MM/ 6 MM SLEEVES. THE DISCREPANCY WAS DISCOVERED WHEN THEY WERE RECEIVED. INSTRUMENTS WERE NEVER USED IN ANY ACTIVITY. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 6.0 MM /5.0 MM THREADED DRILL SLEEVE-LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9406006 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, 6MM/5MM SLEEVES DISTAL OUTSIDE DIAMETER WAS FOUND TO BE TOO LARGE AND WERE FOUND TO NOT SLIDE THROUGH CORRESPONDING 8MM/6MM SLEEVES. THE DISCREPANCY WAS DISCOVERED WHEN THEY WERE RECEIVED. INSTRUMENTS WERE NEVER USED IN ANY ACTIVITY. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9406003 ↗
• MalfunctionJun 4, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS NOTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8669014 ↗
• InjurySep 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN EXTERNAL FIXATION PROCEDURE ON (B)(6) 2018 A SCHANZ SCREW JAMMED IN THE DRILL SLEEVE AND HEAT WAS GENERATED CAUSING A FRICTION BURN TO THE PATIENT. BOTH ITEMS WERE DISCARDED. A DIFFERENT SCHANZ SCREW WAS USED TO COMPLETE THE SURGERY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 7860791 ↗