N
Patient 1
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 9842799
- MDR report key
- 9842799
- Report number
- 1818910-2020-08272
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-05
- Date received
- 2020-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DR. WARSAW 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ATTUNE PS & CR TRLS SZ 9-10 | ATTUNE INSTRUMENTS : INSTRUMENT CASES | DEPUY IRELAND - 9616671 | FSM | 2545-01-710 | 254501710 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-17 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT RECENTLY THE OPERATING ROOM STAFF HAS BEEN FINDING BLACK SPECS IN THE SETS. THEY ARE VERY SMALL BLACK SPECS. THEY ASKED THE OPERATING ROOM TO SEND ME SAMPLES OF THESE BLACK SPECS. THEY WERE MOSTLY FOUND ON THE BOTTOM OF THE TRAYS INSIDE THE WRAPPERS. A FEW TIMES THEY FOUND SPECS INSIDE THE CORNER PROTECTORS THAT THEY USED. THE INSIDE WRAP WAS WHITE SO THEY ARE EASY TO IDENTIFY. WHAT THEY FOUND WAS THAT THE BLACK BUMPERS ON THE TRAYS WHICH PROVIDES PROTECTION WAS PEELING OFF. PERHAPS DURING THE TRANSPORTATION AND STACKING OF TRAYS THE BUMPER MATERIAL BREAKS DOWN. NOT SURE IF YOU HAVE RECEIVED ANY OTHER CONCERNS ABOUT THIS ISSUE.