NA 292.71Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20886982180862), received between Jan 21, 2020 and Jun 13, 2024 — classified as 6 injuries, 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024 DURING A PROXIMAL FEMUR FRACTURE CASE, DOCTOR HAS GUIDANCE BLOCK PLATE AND HE INSERTED A 1.6 K-WIRE TO SLOT OF THE TOP OF THE GUIDE BLOCK AND INSERTION GUIDE. THE K-WIRE GOT STUCK IN A GUIDE BLOCK AND ITEM REMOVED SUCCESSFULLY BY MOVING THE GUIDE WIRE. THE PATIENT WAS NOT AFFECTED, AND SURGERY DONE SUCCESSFULLY. THIS IS NOTICED HALF OF CASE COMPLETED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532043 ↗
• InjuryAug 3, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ORIF FOR A RIGHT TIBIA PLATEAU FRACTURE, THE KIRSCHNER WIRE IN QUESTION BROKE OFF INSIDE OF THE PATIENT. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15156795 ↗
• InjuryFeb 18, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN SURGICAL PROCEDURE THE 1.6 K WIRE BROKE WHEN ATTEMPTING TO REMOVE. WIRE WAS LEFT IN BONE/ ONE WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR (1) 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13560384 ↗
• InjuryFeb 18, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN SURGICAL PROCEDURE THE 1.6 K WIRE BROKE WHEN ATTEMPTING TO REMOVE. WIRE WAS LEFT IN BONE/ ONE WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13560378 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING FIXATION OF THE PROXIMAL HUMERUS WITH AN UNKNOWN PLATE AND SCREWS THE 1.6MM KIRSCHNER WIRE BROKE WHILE IT WAS USED FOR TEMPORARY FIXATION. THE BROKEN PIECE WAS LEFT INSIDE THE PATIENT. THE SURGEON FIXED THE FRACTURE AND OUT SCREWS THROUGH THE PLATE. HE DID NOT USE ANOTHER K WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092104 ↗
• InjuryMar 16, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT OLECRANON NONUNION WITH DISTAL RADIUS AUTOGRAFT, REMOVAL OF RIGHT RADIAL HEAD PROSTHETIC SECONDARY TO LOOSENING, REVISION RIGHT RADIAL HEAD ARTHROPLASTY AND REMOVAL OF FAILED TENSION BAND CONSTRUCT. THE IMPLANTS REMOVED WERE SYNTHES RADIAL HEAD PROSTHETIC AND TENSION BAND WIRE CONSTRUCT WHEREIN TWO (2) K-WIRES WERE LOOSE. ON (B)(6) 2016, AFTER SUSTAINING A FALL WHICH RESULTED IN AN OLECRANON AND COMMINUTED RADIAL HEAD FRACTURE, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF OLECRANON FRACTURE AND ENDO-PROSTHETIC REPLACEMENT OF THE PROXIMAL RADIUS. THE PATIENT WAS IMPLANTED WITH A SYNTHES RADIAL HEAD AND STEM. POST-OPERATIVELY, THE PATIENT HAD IMPROVEMENT BUT STARTED NOTING WORSENING PAIN AND ISSUES WITH HER HARDWARE. ON (B)(6) 2016, THE PATIENT UNDERWENT A PARTIAL REMOVAL OF THE EXPOSED HARDWARE FROM THE TENSION BAND WIRING BUT WAS NOT FULLY REMOVED SINCE THERE WAS NO CONCERN FOR INFECTION. ON (B)(6) 2017, DURING A DOCTOR'S VISIT, THE PATIENT CONTINUES TO REPORT THAT SHE IS BACK TO DOING ALL OF HER NORMAL ACTIVITIES WITHOUT RESTRICTIONS. SHE IS HAVING ONLY O

  Patient problems: No Code Available; Pain

  MAUDE report 9834961 ↗
• InjuryMar 3, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE OF 2010, A PATIENT UNDERWENT A SURGERY DUE TO A LEFT PATELLAR FRACTURE. PATIENT'S HARDWARE WHICH WAS A 1.6MM K-WIRE AND 2.0MM K-WIRE WERE BROKEN POSTOPERATIVELY. ANOTHER SURGERY WAS DONE ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1)1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9781042 ↗
• InjuryJan 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A REMOVAL OF K WIRE FROM A BONE DUE TO A TEMPORARY FIXATION, THE WIRE BROKE AND PART OF IT WAS LEFT IN TIBIA. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN EXTRACTION INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR PC-(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9614267 ↗