NA 900.721Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982256324), received between Nov 9, 2018 and Jan 10, 2024 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS FURTHER REPORTED THE FRAGMENTS WERE NOT REMOVED AND NO ADDITIONAL PROCEDURES WERE DONE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18484475 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE DRILLING FOR WITH A 2.7 CANNULATED DRILL BIT, THE WIRE BECAME INCARCERATED INSIDE OF THE DRILL BIT AND WAS PULLED OUT. IT APPEARED THAT THE SURGEON WAS DRILLING AT AN ANGLE AND IT CAUSED THE WIRE TO BIND UP INSIDE OF DRILL BIT. ANOTHER DRILL BIT AND WIRE WERE SELECTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS 5 MINUTES SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE 1.25MM NON-THREADED GUIDE WIRE 150MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414306 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023, WHILE THE SURGEON WAS DRILLING FOR A SCREW, THE WIRE WAS PULLED OUT BY THE DRILL BIT. THE WIRE WAS UNTHREADED AND THE DRILL BIT ¿SWALLOWED¿ THE WHOLE WIRE, WHICH LIKELY LED TO IT BEING PULLED OUT. THERE WERE NO ADVERSE EVENTS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 1.25MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 2 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305277 ↗
• InjuryAug 17, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE DRILLING FOR CANNULATED SCREWS WITH A CANNULATED DRILL BIT, A PORTION OF THE GUIDE WIRE BROKE OFF IN THE MEDIAL DISTAL TIBIA AND THE PORTION OF THE GUIDE WIRE WAS TOO DEEP IN THE TIBIA TO RETRIEVE. IT WAS LEFT IN. FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); UNK - SCREWS: 4.0 MM CANNULATED (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); 2.7MM CANNULATED DRILL BIT (PART# 310.67; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.25MM NON-THREADED GUIDE WIRE 150MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12331248 ↗
• MalfunctionJun 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A GUIDE WIRE CAME IN BENT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.25MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682910 ↗
• MalfunctionNov 9, 2018Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, THE SURGEON INSERTED THE CANNULATED SCREWS WITHOUT DRILLING OVER THE K-WIRES. X-RAY WAS PERFORMED, AND IT WAS FOUND THERE WAS A METALLIC, WIGGLY, DRILLING PIECE INSIDE THE TIP OF THE SCREW. THE SURGEON CHECKED THE K- WIRES THAT WERE STRIPPED BUT THERE WAS NO ISSUE. THEY COULD NOT DETERMINE WHAT THE METALLIC PIECE WAS. THE SURGEON DID NOT ATTEMPT TO EXTRACT THE METALLIC OBJECT DUE TO RISK OF FURTHER DAMAGE TO THE FRACTURE. THE SURGEON DECIDED TO LEAVE IT INSIDE THE PATIENT¿S BONE AND COMPLETE THE SURGERY. THERE WAS A 2-MINUTE SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/50MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054623 ↗
• MalfunctionNov 9, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, THE SURGEON INSERTED THE CANNULATED SCREWS WITHOUT DRILLING OVER THE K-WIRES. X-RAY WAS PERFORMED, AND IT WAS FOUND THERE WAS A METALLIC, WIGGLY, DRILLING PIECE INSIDE THE TIP OF THE SCREW. THE SURGEON CHECKED THE K- WIRES THAT WERE STRIPPED BUT THERE WAS NO ISSUE. THEY COULD NOT DETERMINE WHAT THE METALLIC PIECE WAS. THE SURGEON DID NOT ATTEMPT TO EXTRACT THE METALLIC OBJECT DUE TO RISK OF FURTHER DAMAGE TO THE FRACTURE. THE SURGEON DECIDED TO LEAVE IT INSIDE THE PATIENT¿S BONE AND COMPLETE THE SURGERY. THERE WAS A 2-MINUTE SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 1.25MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054617 ↗