GPS 3 MINI TUBE ONLY
Received Nov 27, 2018
Report 0001825034-2018-10650 · MDR key 8105558
Device
Generic name
Supplies, Blood-bank
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
800-0745
Lot number
600981
Product problems
- Device Difficult to Setup or Prepare
- Device Difficult to Setup or Prepare
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE ON THE PATIENT'S MEDIAL COLLATERAL TENDON, THE GPS KIT WAS USED, HOWEVER, PLATELET RICH PLASMA (PRP) DID NOT SEPARATE AS IT WAS MEANT TO. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem
RECEIVED LOT NUMBER OF DEVICE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS NO DEVICE OR PHOTOS WERE RECEIVED AND THE CONDITION OF THE COMPONENT IS UNKNOWN DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED.