QUICKSET GRATER HANDLE ASSMB
Received Mar 13, 2018 · Event occurred Feb 20, 2018
Report 1818910-2018-54994 · MDR key 7335380
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT PRODUCT CODE IS SOLD INTERNATIONALLY. IT IS SOLD IN THE US UNDER A DIFFERENT PRODUCT CODE.
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTION POINT BETWEEN THE REAMER AND HUDSON ADAPTOR BROKE OFF. THE WHITE REAMER HANDLE SLEEVE IS CRACKED. NO SURGICAL DELAY .NO PIECES OF INSTRUMENTATION LEFT IN THE PATIENT.