Innomed, Inc. 3450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840277105547), received between Mar 4, 2019 and Sep 27, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2020Break; Break

  REPORT MW5095964 WAS RECEIVED AT INNOMED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ON 8/28/2020 WITH FOLLOWING EVENT DESCRIPTION DOCUMENTED: "PATIENT HAVING SCHEDULED KNEE SURGERY. IN ONE OF THE EXTRA INSTRUMENT TRAYS THAT IS OCCASIONALLY USED. THERE WAS A SOFT TISSUE ELEVATOR NOTED TO BE BROKEN. INSTRUMENT WAS TAKEN OUT OF THE TRAY AND A NEW INSTRUMENT WAS OBTAINED. DID NOT REACH THE PATIENT. NO PATIENT HARM. FDA SAFETY REPORT ID #(B)(4). RESPONSE: IT IS CUSTOMARY FOR INNOMED TO RECEIVE THE AFFECTED DEVICE FOR EVALUATION AND INSPECTION. INNOMED WAS UNABLE TO CONTACT THE INITIAL REPORTER FOR REQUEST OF RETRIEVAL OF THE AFFECTED DEVICE AS THIS INFORMATION WAS NOT PROVIDED IN THE REPORT. INNOMED SURVEYED ITS INTERNAL COMPLAINTS DATABASE TO DETERMINE IF THERE WERE ANY ENTRIES OF THE PART WITH THE SAME DESCRIBED ISSUE. NO ENTRIES WERE FOUND. ADDITIONALLY, CURRENT INVENTORY OF THE PART WAS SURVEYED FOR THE DESCRIBED ISSUE. NONE WERE AFFECTED. THE DEVICE HAS BEEN ON THE MARKET SINCE FEBRUARY OF 2004, AND THIS IS THE FIRST ISSUE OF ITS KIND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10591239 ↗
• MalfunctionMar 4, 2019Material Fragmentation; Material Fragmentation

  REPORT MW5083220 WAS RECEIVED AT INNOMED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ON 2/4/2019 WITH FOLLOWING EVENT DESCRIPTION DOCUMENTED: PATIENT IN SURGERY FOR TOTAL HIP ARTHROPLASTY. A PERIOSTEAL ELEVATOR (CHISEL TYPE PRODUCT) # 3450 BEING UTILIZED BY THE SURGEON BROKE. ALL PIECES RETRIEVED. NO HARM TO PATIENT. REFERRED TO MANAGER OF CENTRAL STERILE TO ADDRESS. RESPONSE: INNOMED CONTACTED THE INITIAL REPORTER ON THE DAY THE DEVICE WAS RECEIVED AND REQUESTED TO HAVE IT RETURNED FOR AN EVALUATION. RETURN AUTHORIZATION NUMBER (B)(4) AND STERILIZATION CONFIRMATION FORM WERE FORWARDED ON THE ABOVE REFERENCED DATE. THE INTERNAL COMPLAINTS DATABASE WAS SURVEYED FOR THE ABOVE DESCRIBED ISSUE. UPON RECEIPT AT INNOMED ON 2/11/2019, THE DEVICE WAS INSPECTED AND EVALUATED BY QUALITY CONTROL. THE FOLLOWING RESULTS WERE DOCUMENTED: PERFORMED EVALUATION OF FAILURE AND FOUND DAMAGE TO THE WORKING END THAT INDICATES THE INSTRUMENT WAS USED IN A LEVER MOTION ON A HARD OBJECT. SEE ATTACHED PICTURES. THE TIP IN THREE PLACES IS ROLLED DOWNWARD INDICATING A FORCE WAS USED THAT EXCEEDED THE FORCE REQUIRED TO ELEVATE PERIOSTEAL TISSUE. THIS INSTRUMENT WAS DESIGNED TO ELEVATE THE PERIOSTEAL T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387106 ↗