FDA Adverse Event
Malfunction
Summary report: N
FLIPCUTTER III DRILL
MDR report key: 14352997
·
Received May 11, 2022
Report
- Report Number
- 14352997
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Date of Event
- April 11, 2022
- Report Date
- May 4, 2022
- Manufacturer
- T.A.G MEDICAL PRODUCTS CORPORATION LTD.
- Product Code
- HTO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ARTHREX FLIPCUTTER III DRILL BROKE IN PATIENT'S KNEE DURING ACL (ANTERIOR CRUCIATE LIGAMENT) REPAIR. ALL PIECES RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1996929 | FLIPCUTTER III DRILL | REAMER | HTO | T.A.G MEDICAL PRODUCTS CORPORATION LTD. | 22A25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |