NA 900.722Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982256331), received between Jul 3, 2018 and Sep 5, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22986020 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE THE SURGEON WAS DRILLING OVER A WIRE, IT WAS REPORTED THAT THE WIRE WAS STUCK INSIDE DRILL BIT LOSING HIS PLACE. A NEW WIRE WAS PLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7MM CANNULATED DRILL BIT/QC 160MM THIS IS REPORT 2 OF FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462852 ↗
• InjuryApr 16, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A ORIF PATELLA PROCEDURE. DURING THE OPEN REDUCTION INTERNAL FIXATION OF PATELLA PROCEDURE, THE SURGEON BENT A 1.25MM THREADED GUIDE WIRE WHILE IN THE BONE. WHEN HE BACKED IT OUT USING A MINI DRIVER THE TIP OF THE GUIDE WIRE BROKE OFF LEAVING THE THREADS INSIDE THE BONE. A SECOND GUIDE WIRE WAS USED BUT WAS INSERTED STRAIGHT THIS TIME. AFTER THE SURGEON OVER DRILLED WITH THE 2.7 CANNULATED DRILL BIT THE GUIDE WIRE CAME OUT WITH THE DRILL BIT BUT THE THREADED TIP OF THE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. AFTER PUTTING IN THE SCREW A THIRD NON-THREADED GUIDE WIRE WAS USED TO PUT IN THE LAST SCREW WITH NO INCIDENT. THERE WERE FRAGMENTS ARE GENERATED AND THE SURGEON LEFT THE BROKEN TIP OF THE GUIDE WIRES IN THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN MINI DRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). 2.7 CANNULATED DRILL BIT (PART# 310.67; LOT# UNKNOWN; QUANTITY:1). UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPO

  Patient problems: Foreign Body In Patient

  MAUDE report 11678946 ↗
• InjuryApr 16, 2021Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A ORIF PATELLA PROCEDURE. DURING THE OPEN REDUCTION INTERNAL FIXATION OF PATELLA PROCEDURE, THE SURGEON BENT A 1.25MM THREADED GUIDE WIRE WHILE IN THE BONE. WHEN HE BACKED IT OUT USING A MINI DRIVER THE TIP OF THE GUIDE WIRE BROKE OFF LEAVING THE THREADS INSIDE THE BONE. A SECOND GUIDE WIRE WAS USED BUT WAS INSERTED STRAIGHT THIS TIME. AFTER THE SURGEON OVER DRILLED WITH THE 2.7 CANNULATED DRILL BIT THE GUIDE WIRE CAME OUT WITH THE DRILL BIT BUT THE THREADED TIP OF THE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. AFTER PUTTING IN THE SCREW A THIRD NON-THREADED GUIDE WIRE WAS USED TO PUT IN THE LAST SCREW WITH NO INCIDENT. THERE WERE FRAGMENTS ARE GENERATED AND THE SURGEON LEFT THE BROKEN TIP OF THE GUIDE WIRES IN THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN MINI DRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). 2.7 CANNULATED DRILL BIT (PART# 310.67; LOT# UNKNOWN; QUANTITY:1). UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPO

  Patient problems: Foreign Body In Patient

  MAUDE report 11678944 ↗
• InjuryAug 29, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE TIP OF THE THREADED GUIDE WIRE FOR CANNULATED SCREW BROKE OFF DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE AND THE GUIDE WIRE LEFT IN THE BONE. THERE WAS PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.25MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7829700 ↗
• MalfunctionJul 3, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4) , A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT IS FOR A 1.25MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7658260 ↗