RECLAIM 2975-00-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295155928), received between Nov 15, 2018 and Sep 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT THE REAMER T HANDLE WAS FOUND TO BE BROKEN DURING THE CASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446335 ↗
• MalfunctionJul 8, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE BLACK MATERIAL ON T HANDLE IS BECOMING WORN/CRACKED AT TOP. NURSES NOTICED AND PULLED FROM SET BEFORE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955498 ↗
• MalfunctionNov 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  BLACK T-HANDLE WOULD NOT ENGAGE ON TO REAMERS. FINISHED SURGERY WITH SIMILAR HANDLE. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075475 ↗
• MalfunctionNov 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  BLACK T-HANDLE WOULD NOT ENGAGE ON TO REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075445 ↗