N
Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE AN INVESTIGATION OF THE DEVICE HAS BEEN COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. UDI #: (01) (B)(4), (17) (B)(4),(10) (B)(4).
MAUDE MDR 9705695
- MDR report key
- 9705695
- Report number
- 0001526350-2020-00165
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-20
- Date received
- 2020-02-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTINA ARNT
- Address
- 56 E. BELL DRIVE WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FAN SPRAY KIT | LAVAGE, JET | ZIMMER SURGICAL, INC. | FQH | 00515047601 | 64579335 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-13 | 0 | 1. O |
Event Narratives#
D
Patient 1
WAS REPORTED THAT THE PULSAVAC TIP DISCONNECTED DURING USE. VIBRATION ALONE CAUSED THE BLUE LOCKING MECHANISM TO LOOSEN. A PIECE OF THE DEVICE FELL INTO THE PATIENT WOUND AND WAS RETRIEVED AND REASSEMBLED TO THE PULSAVAC TO COMPLETE CASE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.