CONMED C5012ARecalls & reported problems
Conmed Corporation · ACROMIOPLASTY ELECTRODE (ELECTRODE ONLY) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854030646), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2022Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, A53-381-406, ACROMIOPLASTY ELECTRODE, 165MM WAS BEING USED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2022 AND ¿THE BLACK SHEATH OF THE A53-381-406 ((B)(4)) ELECTRODE DISINTEGRATES WHEN THE ELECTRODE IS USED IN THE PATIENT AND LEAVES MANY PARTICLES INSIDE THE SHOULDER. THE SURGEON HAS TRIED TO REMOVE AS MANY PARTICLES AS POSSIBLE, BUT SOME REMAIN IN THE JOINT.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE THAT DISINTEGRATED WAS THE A53-381-406 AND ¿ALL FRAGMENTS WERE REMOVED WITH ARTHROPUMP WASHING AND SUCTION¿. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE. THE PATIENT IS DOING WELL. THERE WAS NO ALLEGATION AGAINST THE (B)(4), ACROMIOPLASTY ELECTRODE AND IT WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14354960 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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