NA 313.939Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587037127), received between Nov 15, 2018 and Sep 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported two IMF screwdriver blades are defective. They are not working properly, and are getting complaints that they are broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770293 ↗
• MalfunctionSep 15, 2026Break

  It was reported two IMF screwdriver blades are defective. They are not working properly, and are getting complaints that they are broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770268 ↗
• MalfunctionDec 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED DURING THE LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED. IT WAS NOTICED DURING THE INSPECTION THAT THE SCREWDRIVER SHAFT DOES NOT FIT INTO THE HANDPIECE. THERE WAS NO REPORT OF CUSTOMER COMPLAINT, NO PATIENT IMPACT, AND NO SURGICAL DELAY THIS REPORT IS FOR 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376307 ↗
• MalfunctionApr 19, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 THERE WAS A CONTACT ISSUE BETWEEN SCREWDRIVER SHAFT AND SCREWS. THE SCREWDRIVER WAS BROKEN. THE PATIENT OUTCOME IS REPORTED AS OKAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147448 ↗
• MalfunctionOct 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER WAS FOUND TO BE BROKEN WHEN SET WAS OPENED FOR A CASE. IT IS UNKNOWN HOW OR WHEN IT WAS BROKEN. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) 2.4/3.0MM CRUCIFORM SCREWDRIVER BLADE WITH HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10742281 ↗
• MalfunctionJul 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A STERNAL CLOSURE CASE, THE CRUCIFORM SCREWDRIVER BLADE TIP BROKE ON ONE BLADE DURING USE AND THE SECOND BLADE WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR 1 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10241862 ↗
• MalfunctionNov 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON OCTOBER 31, 2018, DURING INSPECTION IN THE STERILE PROCESSING DEPARTMENT, IT WAS FOUND OUT THAT THE SCREWDRIVER BLADE SHAFT KEEPS STICKING INSIDE THE HOLDING SLEEVE AND IT DID NOT HAPPENED DURING A CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8075147 ↗