CALIPER IN & OUT DIA TO 150MM
Received Apr 3, 2019
Report 9610612-2019-00201 · MDR key 8480380
Device
Product problems
- Mechanical Problem
- Detachment of Device or Device Component
- Mechanical Problem
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION: THE CALIPER WAS AVAILABLE FOR INVESTIGATION DECONTAMINATED. THE CALIPER WAS IN MINT CONDITION, BUT ONE OF THE ADJUSTMENT SCREWS WAS NOT IN PLACE. THE SCREW IS NOT AVAILABLE. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONALE: THE ADJUSTMENT SCREWS ARE NECESSARY TO ADJUST THE MOVEMENT OF THE SLIDING PART OF THE CALIPER, THUS THEY NEED TO BE MOVEABLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE INSTRUMENT MUST BE CHECKED PRIOR TO EACH USE FOR LOOSENED COMPONENTS: INSPECTION, MAINTENANCE AND CHECKS: AFTER EACH COMPLETE CLEANING, DISINFECTING AND DRYING CYCLE, CHECK THAT THE PRODUCT IS DRY, CLEAN, OPERATIONAL, AND FREE OF DAMAGE. CHECK THAT THE PRODUCT FUNCTIONS CORRECTLY. IMMEDIATELY PUT ASIDE DAMAGED OR INOPERATIVE PRODUCTS AND SEND THEM TO AESCULAP TECHNICAL SERVICE. A CAPA IS NOT NECESSARY.
Description of Event or Problem
IT WAS REPORTED THERE WAS AN INTRAOPERATIVE ISSUE WITH THE CALIPER. DURING A HIP SURGERY, IT WAS NOTED THAT THE SCREW WAS MISSING FROM THE CALIPER. THE CALIPER WAS BEING USED ON THE BACK TABLE AND NOT DIRECTLY IN THE OPERATIVE FIELD. THE REPORTER FELT THAT THE SCREW BECOMES LOOSE AND SEPARATES TOO EASILY. THERE WAS NO PATIENT HARM AND AN X-RAY WAS NOT REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.