| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZNN GUIDE WIRE GRIPPER | PASSER, WIRE | ZIMMER BIOMET, INC. | HXI | N/A | 00249001200 | 63107373 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-07-03 | 0 |
Patient 1
(B)(4). REPORT SOURCE, FOREIGN ? EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Patient 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE GUIDE WIRE GRIPPER WAS NOT ABLE TO HOLD THE GUIDE WIRE. ANOTHER DEVICE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. NO ISSUE WAS FOUND UPON EXAMINATION OF THE RETURNED DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. DEVICE ANALYSIS INDICATED THAT THE DEVICE MET SPECIFICATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Patient 1
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.