TRACTION BOOTS, PAIR
Received Dec 17, 2021 · Event occurred Oct 14, 2021
Report 8010652-2021-00034 · MDR key 13023869
Device
Generic name
Table And Attachments, Operating-room
Manufacturer
Holger UllrichModel number
10018800Catalog number
10018800
Lot number
N/A
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF AN ISSUE WITH STRAP RIPPED AT TRACTION BOOTS. IT WAS STATED THAT STRIP AT ONE OF THE TRACTION BOOTS RIPPED DURING THE FIRST USE OF THE TRACTION BOOT. WE DECIDED TO REPORT THE ISSUE DUE TO MAJOR DELAY OF THE SURGERY (ABOUT 30 MINUTES). BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE TRACTION BOOTS WERE REPLACED UNDER WARRANTY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE TRACTION BOOTS DID NOT MEET THEIR SPECIFICATION DUE TO THE STRAP HAVING RIPPED. PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. WHEN THE EVENT OCCURRED THE TRACTION BOOTS WERE DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUES, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTIONS OCCURRED. ACCORDING TO THE REVIEW OF THE COMPLAINTS DATABASE FROM LAST 5 YEARS LIKELIHOOD OF SUCH EVENT IS RARE AND UP TO TWO EVENTS PER YEAR. DUE TO THE FACT THAT CUSTOMER DID NOT PROVIDE AFFECTED TRACTION BOOTS FOR FURTHER INVESTIGATION (THE TRACTION BOOTS WERE DESTROYED BY THE CUSTOMER) WE CAN ONLY ASSUME PROBABLE ROOT CAUSE FOR THIS ISSUE. WE ASSUME THAT THIS ISSUE OCCURRED DUE TO A SUPPLIER FAILURE WHICH IS SIMILAR TO PREVIOUSLY REPORTED COMPLAINTS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY ACTION AT THIS TIME. THE CORRECTION OF H8 USAGE OF THE DEVICE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H8 USAGE OF THE DEVICE. UNKNOWN. CORRECTED H8 USAGE OF THE DEVICE. INITIAL USE.
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWACHT WILL BE SUBMITTED.
Description of Event or Problem
THE FOLLOWING WAS REPORTED TO US. A STRIP AT ONE OF THE TRACTION BOOTS RIPPED DURING THE FIRST USE OF THE TRACTION BOOT. THE CLINIC CONFIRMED THAT THE PATIENT WAS NOT INJURED. THIS INFORMATION WAS RECEIVED ON (B)(6). ON (B)(6) WE RECEIVED FURTHER INFORMATION FROM THE CLINIC. THE SURGERY WAS DELAYED BY 30 MINUTES DUE TO THIS ISSUE.