ASSISTARM AA-SK-KIT10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854043605), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Material Deformation; Material Deformation

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF AN USER FACILITY THAT POST 2-HOUR ROTATOR CUFF PROCEDURE ON (B)(6) 2017, USING THE AA-SK-KIT10, THE PATIENT "GOT NERVE PALSY FROM THE ASSIST ARM BANDAGE." THIS INCIDENT OCCURED TO TWO PATIENT'S OF DR. (B)(6); THE DOCTOR HAS REPORTEDLY NOT DONE FOLLOW UP WITH THIS PATIENT. NO PATIENT INJURY WAS REPORTED. UPON ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE, IT WAS CONFIRMED THE REPORTED SYMPTOMS WERE RELATED TO RADIAL NERVE PALSY. IT WAS ALSO STATED THAT THE PROCEDURE HAD BEEN COMPLETED WITH NO SURGICAL DELAYS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING CURRENT PATIENT STATUS OR IF ADDITIONAL TREATMENT WAS NEEDED AS THE "THE SURGEON DOESN'T REMEMBER EVERYTHING." THIS REPORT IS BEING RAISED ON THE BASIS OF THE REPORTED PATIENT'S RADIAL NERVE PALSY WHOSE STATUS IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7593240 ↗