N
Patient 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
MAUDE MDR 5627603
- MDR report key
- 5627603
- Report number
- 0001822565-2016-01388
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-04-01
- Date received
- 2016-05-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CARRIE SCHNEIDER
- Address
- P.O. BOX 708 WARSAW IN 46581 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZIMMER NATURAL NAIL GUIDE WIRE GRIPPER | HXI | ZIMMER, INC. | HXI | N/A | 00249001200 | 62006692 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-03 | 0 |
Event Narratives#
D
Patient 1
IT IS REPORTED THE GUIDE WIRE GRIPPER WOULD NOT ENGAGE AND GRIP THE GUIDE WIRE DURING USE IN SURGERY.
N
Patient 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
N
Patient 1
DEVICE HISTORY RECORDS WERE PREVIOUSLY REVIEWED WITH NO DEVIATIONS OR ANOMALIES IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THREAD DAMAGE ON THE THREADED ROD. TWO PINS WERE IDENTIFIED TO BE LOOSE. IMPACT MARKS WERE VISIBLE ON BOTH THE SUPERIOR AND INFERIOR SURFACE. DIMENSIONS WERE FOUND CONFORMING TO PRINT SPECIFICATIONS WHERE MEASURED. THE HARDNESS OF THE TOP STRIKE HANDLE WAS FOUND TO BE CONFORMING. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE HAD A POTENTIAL FIELD AGE OF APPROXIMATELY FOUR YEARS. IT IS ALSO UNKNOWN HOW MANY TIMES THE DEVICE HAD BEEN USED DURING THAT TIME. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.