FASTSYSTEM STERILE FIELD POST
Received Oct 4, 2024
Report 3004608878-2024-00118 · MDR key 20370720
Device
Generic name
Surgical Retractor
Manufacturer
Integra Lifesciences Corporation Oh/usaCatalog number
4080
Lot number
6212276
Product problems
- Mechanics Altered
- Mechanics Altered
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FASTSYSTEM STERILE FIELD POST (4080) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION FOUND THAT THE CLAMP JAW OF THE STERILE FIELD POST WAS UNSTABLE WHEN MOUNTED ON THE TEST RAIL. THE BOLT HAD BECOME FLAT AT THE BOTTOM AND MUST BE REPLACED ALONG WITH THE WASHERS. ROOT CAUSE ANALYSIS: THE COMPLAINT REPORTED BY THE CUSTOMER WAS CONFIRMED AS VALID. BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE WAS MOST LIKELY USE-ERROR (CLOSING THE CLAMP WITH NOTHING INSIDE). NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY WAS IDENTIFIED FOR CORRECTION AS A RESULT OF THIS COMPLAINT INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE FASTSYSTEM STERILE FIELD POST (4080) DID NOT STAY TIGHTENED WHEN ATTACHED TO THE TABLE DURING SURGERY. A DELAY OF AT LEAST 30 MINUTES WAS REPORTED AS A RESULT OF LOOKING FOR ANOTHER RETRACTOR USED TO COMPLETE THE SURGERY. THE WAS NO PATIENT INJURY OR DEATH REPORTED.