DIGIT TRAP FINGER GRASPING DEVICE, 20 EA

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW CANNOT NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A LOT HISTORY REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE COMPLAINT, REGARDING ONE DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. NOTE: THIS REPORT IS BEING RESUBMITTED FOLLOWING AN UNSUCCESSFUL SUBMISSION ATTEMPT ON 12AUG21 DUE TO A SYSTEM ERROR.

Description of Event or Problem

THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5102137) ON 19JUL21. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE (B)(4), STATING ¿PRODUCT CAUSED LACERATION TO DIGIT.¿. THE MEDWATCH DID NOT INDICATE SERIOUS INJURY, ONLY MALFUNCTION; THEREFORE, THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE REPORTER AND 3-ATTEMPTS WERE MADE TO GAIN FURTHER INFORMATION. HOWEVER, TO DATE, THE REPORTER HAS NOT RESPONDED TO OUR REQUEST. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.