BONE HOOK HOOK DIA 3/4(1.9CM) SHARP 9IN
Received Sep 15, 2014 · Event occurred Jun 9, 2014
Report 1923569-2014-00015 · MDR key 4088583
Device
Product problems
- Break
- Entrapment of Device
- Difficult to Remove
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
BROKEN RECEIVED (B)(6) 2014 VIA MEDWATCH# WAS NOT ENTERED IN THE REPORT RECORD. IT WAS REPORTED THAT ON (B)(6) 2014, THE TIP OF THE (BONE HOOK) PARTED DURING A SURGICAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED VIA A PHONE CALL FROM THE CUSTOMER ON (B)(6) 2014. IT WAS REPORTED THAT THE BONE HOOK DID IN FACT BREAK INSIDE OF THE PATIENT'S KNEE. APPROXIMATELY 1/16 OF THE END OF THE BONE HOOK IS "STUCK" IN THE PATIENT'S KNEE AT THIS TIME AND IS NOT ABLE TO BE REMOVED BY THE SURGEON. THE CUSTOMER STATED THAT IT IS IMPOSSIBLE TO REMOVE IT. THE PATIENT IS FINE OTHERWISE AND DOESN'T FEEL THE PIECE OF THE BONE HOOK WILL MIGRATE. CAREFUSION WILL NOT BE RECEIVING THE INSTRUMENT FOR EVALUATION BUT THE CUSTOMER DID SENT A PICTURE AND IT IS UPLOADED IN THE ATTACHMENT PORTION OF THE COMPLAINT. NO FURTHER INFORMATION WAS RECEIVED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE WILL NOT BE RECEIVED PER THE CUSTOMER. IF THE DEVICE IS RECEIVED A FOLLOW-UP EMDR WILL BE SUBMITTED.