n.a. 28145WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551095607), received between Dec 7, 2020 and Feb 20, 2025 — classified as 2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE L KNEE ARTHROSCOPY THE KNEE STRUCTURES WERE PROBED, WITH THE DEVICE. UPON CHECKING THE ACL THE HOOK BROKE. THE END WAS UNRETRIEVABLE. ARTHROTOMY WAS PERFORMED TO NO AVAIL. THE PATIENT WILL BE CHECKED IN THE ONGOING WEEK. METAL STILL IN KNEE. THE INITIAL SURGERY WAS ABORTED AND HAD TO SWITCHED TO AN OPEN PROCEDURE (ARTHROTOMY OF KNEE). THE BROKEN OFF PART COULD NOT BE RECOVERED. ADDITIONAL X-RAYS WERE TAKEN. AS THE END OF THE HOOK IS EMBEDDED IN THE KNEE AN INITIAL ABORTED PROCEDURE, A SWITCH TO AN OPEN PROCEDURE, ADDITIONAL X-RAYS AND A PLANNED ADDITIONAL SURGERY, THE EVENT IS DEEMED REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21425473 ↗
• InjuryFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE L KNEE ARTHROSCOPY THE KNEE STRUCTURES WERE PROBED, WITH THE DEVICE. UPON CHECKING THE ACL THE HOOK BROKE. THE END WAS UNRETRIEVABLE. ARTHROTOMY WAS PERFORMED TO NO AVAIL. THE PATIENT WILL BE CHECKED IN THE ONGOING WEEK. METAL STILL IN KNEE. THE INITIAL SURGERY WAS ABORTED AND HAD TO SWITCHED TO AN OPEN PROCEDURE (ARTHROTOMY OF KNEE). THE BROKEN OFF PART COULD NOT BE RECOVERED. ADDITIONAL X-RAYS WERE TAKEN. AS THE END OF THE HOOK IS EMBEDDED IN THE KNEE AN INITIAL ABORTED PROCEDURE, A SWITCH TO AN OPEN PROCEDURE, ADDITIONAL X-RAYS AND A PLANNED ADDITIONAL SURGERY, THE EVENT IS DEEMED REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21425189 ↗
• MalfunctionJan 11, 2021Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): BREAKAGE OF THE INSTRUMENT TIP DURING SURGERY. OPERATION EXTENSION OF 30 MIN.

  Patient problems: Insufficient Information

  MAUDE report 11151361 ↗
• MalfunctionDec 7, 2020Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4). THE HOOK BROKE OFF DURING KNEE ARTHROSCOPY. IT WAS USED FOR ARTHROSCOPIC EXAMINATION AND ELEVATION.

  Patient problems: Insufficient Information

  MAUDE report 10962896 ↗