CONMED 00505217900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854000649), received between Oct 18, 2017 and May 9, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5116554 ON 19APR23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 00505217900, 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, COATED DEVICE THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 09MAR23. THE REPORT STATED, ¿PATIENT ADMITTED AFTER A FALL AND FOUND TO HAVE A FEMORAL NECK FRACTURE. AFTER THE PROCEDURE IT WAS NOTED THAT THERE WAS A SMALL PIECE OF THE SAW BLADE LEFT INSIDE THE PATIENT INCISION. PIECE WAS REMOVED. AN XRAY WAS CONFIRMED NO ADDITIONAL PIECES WERE LEFT IN THE INCISION.¿. FURTHER ASSESSMENT QUESTIONS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897557 ↗
• InjuryApr 12, 2023Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT NUMBER 5114481 RECEIVED ON 21MAR23. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 00505217900 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED, QTY 5. THE REPORT STATES THAT ON (B)(6) 2022 ¿AFTER TOTAL KNEE REPLACEMENT, NOTED SAW BLADE WAS MISSING PIECES. XRAY CONFIRMED PIECE RETAINED. REQUIRED REOPENING OF REMOVAL OF FRAGMENTS.¿. FOR HEALTH EFFECTS THE REPORT LISTED: LACERATION(S) AND FOREIGN BODY IN PATIENT. FURTHER ASSESSMENT COULD NOT BE SENT; HOWEVER, AS THE REPORTER ELECTED TO NOT BE IDENTIFIED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO REOPENING TO RETRIEVE A DEVICE FRAGMENT THAT WAS LEFT IN THE PATIENT..

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 16726569 ↗
• MalfunctionOct 18, 2017Break; Break

  THE USER FACILITY REPORTED TO CONMED (B)(4) THAT DURING A TOTAL KNEE ARTHROSCOPY, THE 00505217900 SAW BLADE BROKE. THE BROKEN PIECE WAS RETRIEVED FROM THE SURGICAL SITE AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6959318 ↗