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. UDI: (B)(4).
MAUDE MDR 8473093
- MDR report key
- 8473093
- Report number
- 1221934-2019-56733
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-25
- Date received
- 2019-04-02
- 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
- KARA DITTY-BOVARD
- Address
- 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
- Phone
- 610-610-6103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MENISCAL DEPLOYMENT GUN | ORTHOPAEDIC CERCLAGE APPLIER | DEPUY MITEK LLC US | GEF | 228143 | L502531 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-02 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE FIRST IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS, THE IMPLANT WOULD NOT DISCHARGE FROM THE GUN DESPITE HAVING REPEATEDLY PRESSING THE TRIGGER. THE SECOND IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS AND FIRED THE FIRST IMPLANT, WHEN POSITIONING THE SECOND IMPLANT A FEW MILLIMETERS, EVERY SYSTEM CAME OUT OF THE APPLICATOR. THE SURGEON DID NOT WANT TO CONTINUE HURTING THE MENISCUS WITH MENISCAL SUTURE AND SO CHOSE TO DO A MENISCECTOMY INSTEAD.