DR. DON'S ARM SUSPENSION KIT; (051724); STERILE
Received Sep 21, 2020 · Event occurred May 1, 2020
Report 1836161-2020-00044 · MDR key 10559486
Device
Generic name
Patient Positioning - Shoulder
Manufacturer
Aspen Surgical Products, CaledoniaModel number
711503Lot number
021418
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.
Description of Event or Problem
ASPEN SURGICAL RECEIVED A MEDWATCH REPORT (UF/IMPORTER REPORT # (B)(4)) INDICATING THAT DURING A SHOULDER SURGERY, THE STRAP CONNECTING THE RING TO THE SUSPENSION DEVICE BROKE, CAUSING THE ARM TO FALL DURING THE SURGICAL PROCEDURE. NO PATIENT HARM WAS REPORTED. THIS INCIDENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER (B)(4).