NA 312.28Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982187703), received between Apr 24, 2017 and May 10, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT A STANDING EQUINE FRACTURE PROCEDURE WAS PERFORMED ON (B)(6) 2024, AND THE SLEEVE WAS BROKEN WHEN THE PATIENT (A HORSE) THREW HIS HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND THE PATIENT WAS REPORTED TO BE DOING WELL. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 3.5MM/2.5MM DOUBLE DRILL SLEEVE . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286615 ↗
• MalfunctionFeb 10, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT STAFF HAVE INDICATED A DOUBLE DRILL SLEEVE FROM THEIR SMALL FRAG SET IS BENT AND THE DRILL BIT WILL NO LONGER PROPERLY GLIDE THROUGH THE SLEEVE. ITEM HAS BEEN DISCARDED. NO PATIENT ISSUES AND NO SURGICAL DELAY AS THIS DID NOT OCCUR INTRA-OP. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM/2.5MM DOUBLE DRILL SLEEVE THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310797 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: DRILL BIT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VA PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905335 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: DRILL BIT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VA PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905128 ↗
• MalfunctionMay 27, 2020Break; Break

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE UNIVERSAL DRILL SLEEVE (312.28) WAS BROKEN. THE SHARP EDGE WAS CHIPPED AND BURRED NOT ALLOWING PROPER USE OR PLACEMENT FOR SURGERY. THE ITEM WAS DISCARDED AND NO PICTURE WAS TAKEN. THIS REPORT IS FOR 1 3.5MM/2.5MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093575 ↗
• MalfunctionMar 18, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON JANUARY 1, 2020, THE DRILL BIT BROKE INSIDE OF A DRILL GUIDE AND BECAME STUCK. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: DRILL GUIDE (PART: 312.280, LOT: 2502340, QUANTITY: 1). THIS REPORT IS FOR A 2.5MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847257 ↗
• MalfunctionSep 20, 2017Bent; Bent

  IT WAS REPORTED THAT A DRILL GUIDE WAS FOUND MISSHAPEN. IT APPEARED THAT ONE SIDE OF IT HAD BEEN CRUSHED; IT WAS NO LONGER A CIRCLE, BUT AN OVAL. THIS WAS DISCOVERED BEFORE A PROXIMAL HUMERUS OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2017, BEFORE THE PATIENT ENTERED THE ROOM. ANOTHER INSTRUMENT WAS AVAILABLE FOR USE AND THERE WAS NO IMPACT ON THE UPCOMING CASE. SUBSEQUENTLY, ONE OF THE ENDS (ONE OF THE TINES) BROKE OFF OF REDUCTION FORCEPS DURING THIS CASE. WHILE THE SURGEON WAS USING THE CLAMP TO REDUCE THE FRACTURE, ONE OF THE ENDS BROKE OFF. THE SURGEON REMOVED THE BROKEN PIECE FROM THE SURGICAL FIELD, AND CONTINUED ON WITH THE REDUCTION. ANOTHER INSTRUMENT WAS AVAILABLE FOR USE. THERE WAS A SURGICAL DELAY OF A FEW SECONDS. NO FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6881270 ↗
• MalfunctionApr 24, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT IS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2017, WHILE SURGEON WAS DRILLING USING THE DRILL SLEEVE, THE DRILL SLEEVE BROKE INTO TWO PIECES. NO PIECES FELL INTO THE PATIENT AND NO SURGICAL DELAY WAS REPORTED. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO HARM TO PATIENT. THIS REPORT IS FOR ONE (1) DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517311 ↗