NA 395.922Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982200938), received between Oct 20, 2022 and Apr 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE EXTERNAL FIXATION SURGERY FOR OPEN FOREARM FRACTURE WITH THE DRILL SLEEVE IN QUESTION. IN THE SURGERY, WHEN TRYING TO PIERCE THE SELDRILL IN QUESTION USING THE SLEEVE IN QUESTION, THE SELDRILL AND THE SLEEVE INTERFERE IN THE MIDDLE, AND THE SURFACE OF THE SELDRILL'S SHAFT PART WAS SCRAPED AND BURRS GENERATED, MAKING IT IMPOSSIBLE TO INSERT THE SELDRILL FURTHER. THE SURGERY WAS COMPLETED WITH A NEW SLEEVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THE SURGEON USED A TOTAL OF 4 SELDRILL IN THIS SURGERY, BUT THERE WERE NO PROBLEMS OTHER THAN THIS PRODUCT. SURGEON CONFIRMED BY THE X-RAY, THERE ARE NO PIECES LEFT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM THREADED DRILL SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738229 ↗
• MalfunctionMar 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN 4AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE EXTERNAL FIXATION SURGERY FOR DISTAL PART OF UPPER WRIST WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF AN EVENT IN WHICH A CELL DRILL F4-125MM BECAME STUCK IN THE SLEEVE AND COULD NOT ADVANCE. IN THIS SURGERY, TWO OTHER F2.5/4.0 AND ONE F3.0/4.0 WERE USED, BUT THEY COULD BE USED WITHOUT INTERFERENCE IN THE SLEEVE. BECAUSE THE PRODUCT IN QUESTION WAS ONE OF THE LAST, THE SURGEON INSERTED THE CELL DRILL WITHOUT USING A SLEEVE. SALES CONFIRMED THAT THE CELL DRILL WAS INTERFERING WITH THE SLEEVE BY LOOKING AT THE ACTUAL PRODUCTS. THE SURGEON COMMENTED THAT THE SLEEVE ITSELF IS MADE TIGHT, SO IT MIGHT BE BETTER TO USE IT MORE CAREFULLY TO AVOID SLANTING WHEN USING THE NARROWER SIZES. THE SAME EVENT OCCURRED SIX MONTHS AGO. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI (PART# 494.769S; LOT# 619P075; QUANTITY: 1), SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI (PART# 494.769S; LOT# 660P588; QUANTITY: 1), SELDRILL-SCHANZSCR Ø4/3 L100/20 TI (PART# 494.772S; LOT# 9L63185; QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16532213 ↗
• MalfunctionOct 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT EXTERNAL FIXATION FOR A DISTAL RADIUS FRACTURE WITH THE PRODUCTS IN QUESTION. WITH THE RODS AND CLAMPS OF A Z FRAME EXTERNAL FIXATOR, THE SURGEON ATTEMPTED TO DRILL A 2.5/4.0 SELDRILL USING A 4.0 MM THREADED DRILL SLEEVE, BUT THE SELDRILL JAMMED IN THE SLEEVE AND COULD NOT BE INSERTED INTO THE BONE. HE CHECKED IF HE HAD INSERTED THE SELDRILL AT AN ANGLE, BUT IT STILL DID NOT PASS. HE TRIED TO PUNCTURE WITH OTHER SELDRILLS, BUT ALL OF THEM EXPERIENCED INTERFERENCE IN THE SLEEVE. THE SURGEON WAS ABLE TO COMPLETE THIS STEP USING ANOTHER PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 30 MINUTES. AFTER CLEANING THE DRILL SLEEVE, IT IS FOUND THAT THE INSIDE OF THE SLEEVE THERE WAS A BURR-LIKE OBJECT HAD FORMED AROUND THE CIRCUMFERENCE OF THE SLEEVE, CAUSING THE 4.0 CELL DRILL TO POKE INTO IT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM THREADED DRILL SLEEVE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639323 ↗