PIVOT GUARDIAN DIRECT FINE TRACTION
Received Dec 28, 2022 · Event occurred Nov 14, 2022
Report 0002936485-2022-00800 · MDR key 16064388
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
3105000306Catalog number
3105000306
Product problems
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
Unknown
- Hip Fracture
- No Clinical Signs, Symptoms or Conditions
- Hip Fracture
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A PATIENT INJURY OF A BLOWN OUT WALL OF THE PATIENT'S FEMUR.
Additional Manufacturer Narrative
THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: PATIENT INJURY OF A BLOWN OUT WALL OF FEMUR. PROBABLE ROOT CAUSE: DESIGN: POOR CONNECTOR DESIGNS OR TOLERATING. CONNECTOR IS LOOSE. CONNECTOR UNABLE TO HOLD FORCE. UNCLEAR FEEDBACK IF MECHANISM IS FULLY LOCKED/ATTACHED . CASTERS SLIP ON FLOOR . VERTICAL SPARS COLLAPSE . HORIZONTAL SPARS COLLAPSE . FINE TRACTION ELEMENT PIVOTS UNINTENTIONALLY. BOOT DISCONNECTS FROM FINE TRACTION ELEMENT . TABLETOP EXTENSION CUSHION LIFTS OR SLIDES UNDER FORCE USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A PATIENT INJURY OF A BLOWN OUT WALL OF THE PATIENT'S FEMUR.