N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
MAUDE MDR 7635751
- MDR report key
- 7635751
- Report number
- 9610612-2018-00254
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-08
- Date received
- 2018-06-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYPERT BONE RONGEUR 8/360MM | BONE RONGEURS AND BONE CUTTING FORC | AESCULAP AG | HTX | FG052R | FG052R | 4509212949 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-25 | 0 | 1. O |
Event Narratives#
D
Patient 1
COUNTRY OF COMPLAINT: (B)(6). IN ORDER TO CREATE SPACE FOR THE BLOOD VESSELS AND NERVES BETWEEN THE FIRST RIB AND CLAVICULA THE FIRST RIB HAD TO BE REMOVED. FIRST STEP IS TO CUT THE FIRST RIB (A PIECE) WITH A BONE CUTTING FORCEPS, SECOND STEP IS TO MAKE THE SHARP EDGES AS A RESULT OF CUTTING LESS SHARP IN TO PREVENT STABBING THROUGH THE PLEARA VISCERALE WHICH CAN CAUSE A PNEUMOTHORAX, OR STABBING THROUGH THE BLOOD VESSELS OR NERVES. FOR THIS SECOND STEP THE FG052R IS SUPPOSED TO BITE SMALL BITS FROM THE SHARP EDGES WITHOUT USING TO MUCH PRESSURE BECAUSE TO MUCH PRESSURE CAN CAUSE THE RIB TO SHATTER OR SPLINTER WHICH IS EXACTLY WHAT HAPPENED. A SPLINTER PUNCTURED THE PLEURA VISCERALE. TO PREVENT A PNEUMOTHORAX AFTER SURGERY THE OR TEAM PLACED A SMALL THORAXDRAIN. THE FG052R WAS DELIVERED ON 8 MAY AND USED FOR THE FIRST TIME. THE INITIAL FEEDBACK ON 8 MAY (NO COMPLAINT) ONLY STATED THE FG052R BEING BLUNT. THE COMPLAINT WAS RECEIVED (B)(6) MAY. UNFORTUNATELY IN BETWEEN THIS DATES THE FG052R WAS BEING CUT BY OUR INSTRUMENT REPAIR DEPARTMENT. THE SURGEON WHO SUBMITTED THE COMPLAINT TRIED THE SAME FG052R AFTER IT WAS CUT WITH THE SAME RESULT. IT DOES NOT CUT WITHOUT A LOT OF PRESSURE WHICH ONLY LEAVES THE QUESTION I THINK IF THE DOUBLE HINGE CREATES ENOUGH LEVERAGE.