NA 207.750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982148551), received between Feb 14, 2018 and Sep 18, 2023 — classified as 2 injuries, 3 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. 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 18, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DOCTOR WAS PLACING A 4.0 LONG THREAD 50MM CANNULATED SCREW INTO THE MEDIAL MALLEOLUS DURING AN ANKLE ORIF. THE SCREW ¿ACCORDIONED¿ AND BROKE OFF IN THE PATIENT. THE PHYSICIAN FELT NO RESISTANCE WHEN INSERTING THE SCREW TO INDICATE HE WAS HITTING ANOTHER SCREW AND THERE WAS NO AUDIBLE SOUND INDICATING SCREW COLLISION. THERE WERE SIXTY (60) MINUTES OF SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17765808 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/50MM.THIS IS REPORT 8 OF 18 FOR COMPLAINT (B)(4)

  Patient problems: Pain

  MAUDE report 12797360 ↗
• InjuryJan 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THAT THE CANNULATED SCREW BROKE DURING AN INSERTION AND AGAIN WHILE BEING REMOVED. THE SCREW AND FRAGMENTS WERE COMPLETELY REMOVED AND REPLACED WITH A CORTEX SCREW AND WASHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF ONE (1) HOUR CAUSED BY THE REMOVAL. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258013 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE CANNULATED SCREW LONG THREAD BROKE WHILE IMPLANTING. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT THEY COULD NOT BE RETRIEVED. XRAYS WERE PERFORMED INTRA-OPERATIVELY. THE DEVICE REMAINS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 15-MINUTE SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.6MM THREADED GUIDE WIRE (PART# 292.72, LOT# UNKNOWN, QUANTITY# 4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7914039 ↗
• MalfunctionFeb 14, 2018Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY FOR OPEN REDUCTION INTERNAL FIXATION OF RIGHT MEDIAL EPICONDYLE FRACTURE ON (B)(6) 2018, WHEN THE SURGEON WAS TRYING TO HOLD THE FRACTURE WITH THE K-WIRE AND TRYING TO IMPLANT A 4.0MM CANNULATED SCREW LONG THREAD/50MM, THE THREADS ON THE SCREW STARTED TO UNRAVEL AND BECAME LOOSE. THE SURGEON HAD TO REMOVE THE SCREW. ALMOST 99% OF THE SCREW WAS RETRIEVED BUT A PORTION OF IT WAS LEFT IN THE PATIENT. ANOTHER AVAILABLE 4.0MM CANNULATED SCREW LONG THREAD/50MM WAS IMPLANTED IN THE PATIENT. THE PORTION OF THE SCREW THAT WAS LEFT AFTER EXPLANTATION DID NOT INTERFERE WITH THE NEW SCREW THAT WAS IMPLANTED. THERE WAS A SURGICAL DELAY OF ABOUT 3 MINUTES. THE SURGERY WAS COMPLETED WITH EXCELLENT FRACTURE REDUCTION AND THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT MEDICAL PRODUCTS: 1.25MM NON-THREADED GUIDE WIRE 150MM (PART # 900.721, LOT # UNKNOWN, QTY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270298 ↗