NA 62-32440Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613153171096), received between May 25, 2018 and May 24, 2023 — classified as 3 injuries, 4 malfunctions.

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

• InjuryMay 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE REPOSITIONING PIN BROKE OFF AND A PIECE STILL REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997221 ↗
• MalfunctionNov 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SHAFT OF THE BONE REPOSITIONING TOOL BROKE DURING MANIPULATION. THE BROKEN PIECE REMAINS IN BONE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735931 ↗
• InjuryOct 15, 2020Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE, THAT DURING THE PROCEDURE. PART OF THE INSTRUMENT BROKE OFF. THE TIP OF THE BONE REPOSITIONING INSTRUMENT REMAINS IN THE PATIENT. AND AFTER SURGEON DISCRETION, THEY OPTED TO LEAVE IT. THERE ARE NO FURTHER DETAILS AT THIS TIME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683327 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON USED A 2.0MM DRILL BIT TO DRILL THE PILOT HOLE FOR THE REPOSITIONING PIN. THE REPOSITIONING PIN WAS INSERTED WITHOUT PROBLEMS BUT WHEN THE SURGEON WAS MOVING THE BONE, THE PIN BROKE LEAVING THE THREADED PORTION IN THE PATIENT'S BONE. THE SURGEON WAS ABLE TO REMOVE THE TIP FROM THE BONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9564000 ↗
• MalfunctionOct 16, 2019Fracture

  DURING SURGICAL CASE, A REPOSITIONING PIN FRACTURED IN HALF. NO ADVERSE CONSEQUENCES TO PATIENT OR STAFF. NO DELAY IN SURGERY AS BACKUP PRODUCTS WERE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199210 ↗
• InjuryAug 29, 2019Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN THE SURGEON WAS ATTEMPTING TO REDUCE THE FRACTURE. THE TIP OF THE BONE REPOSITIONING INSTRUMENT REMAINS IN THE PATIENT, EVEN THOUGH THE SURGEON DID ATTEMPT TO REMOVE IT FOR APPROXIMATELY ONE HOUR. OTHERWISE, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947234 ↗
• MalfunctionMay 25, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON WAS PULLING ON THE REPOSITIONING PIN AND THE TIP OF THE PIN BROKE OFF. THE TIP WAS LEFT IN THE PATIENT'S ZYGOMA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY NOR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7546114 ↗