NA 207.640Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982148247), received between May 22, 2019 and Sep 17, 2021 — classified as 2 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2021Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD/40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492605 ↗
• InjuryNov 13, 2019Break; Break

  THERE IS NO PLAN TO REMOVE THE THREAD FROM THE PATIENT. CONCOMITANT DEVICES: HAND PIECE POWERED DRIVER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9315459 ↗
• InjurySep 4, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING FINAL TIGHTENING THE SURGEON TORQUED THE SHORT THREAD CANNULATED SCREW HARD ENOUGH FOR THE SCREW HEAD TO BREAK OFF DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE. THE SURGEON WAS USING A 2.5 MM HEX SCREWDRIVER TO REMOVE THE SCREW WHEN THE SCREW HEAD BROKE. THE SURGEON ATTEMPTED TO RETRIEVE THE SHAFT OF THE SCREW USING VICE GRIPS, BUT THE SHAFT BROKE AGAIN, THIS TIME AT THE THREADS. THE THREADED PORTION REMAINS IMPLANTED IN THE PATIENT AND THERE WERE NO COMPLICATIONS. A PORTION OF THE SCREW WAS TOO DEEP TO RETRIEVE AND REMAINS IN THE PATIENT. THERE WAS A SURGICAL DELAY OF AN UNKNOWN NUMBER OF MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN VICE GRIPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY #1); UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY #1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8960417 ↗
• MalfunctionMay 22, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PACKAGE WAS RECEIVED EMPTY. THE ONLY THING INSIDE WAS THE PACKING SLIP WHICH SHOWS THE IMPLANTS WERE SHIPPED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL PRODUCTS FOR THIS EVENT ARE CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A CANNULATED SCREW. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8631593 ↗
• MalfunctionMay 22, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PACKAGE WAS RECEIVED EMPTY. THE ONLY THING INSIDE WAS THE PACKING SLIP WHICH SHOWS THE IMPLANTS WERE SHIPPED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL PRODUCTS FOR THIS EVENT ARE CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A CANNULATED SCREW. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8631587 ↗