SAWBLADES
Received Jul 16, 2013 · Event occurred Jun 17, 2013
Report 3002806535-2013-00129 · MDR key 3229145
Device
Generic name
Blade, Saw, General And Plastic Surgery
Manufacturer
Biomet Uk Ltd.Model number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PATIENT INJURY WAS REPORTED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. MANUFACTURE DATE - UNKNOWN. THIS IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR: 3002806535-2013-00128.
Additional Manufacturer Narrative
PRODUCT WAS RETURNED AND EVALUATED. THE EVALUATION CONFIRMED THAT THE SAW BLADES IN THE KIT COULD ONLY BE USED FOR A CEMENTED PROCEDURE. THE SAWBLADES ARE GENERIC AND ARE CURRENTLY BEING EXCHANGED TO THE CORRECT VERSIONS. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. SEE ALSO: 3002806535-2013-00128.
Description of Event or Problem
IT WAS REPORTED THAT DURING A KNEE PROCEDURE ON (B)(6) 2013, AN OXFORD SHORT ROD INSTRUMENT AND THE CORRECT SAW BLADES WERE MISSING FROM THE LOANER KIT WHICH RESULTED IN A 30-45 MINUTE DELAY IN SURGERY. NO PATIENT INJURY WAS REPORTED.