FDA Adverse Event
Malfunction
Summary report: N
FLEXIBLE REAMER SHAFT, NITINOL, HUDSON
MDR report key: 16403469
·
Received February 20, 2023
Report
- Report Number
- 1220246-2023-06311
- Event Type
- Malfunction
- Date Received
- February 20, 2023
- Date of Event
- February 1, 2023
- Report Date
- February 20, 2023
- Manufacturer
- ARTHREX, INC.
- Product Code
- HSB
- PMA / PMN Number
- K021008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED ON (B)(4) 2023 BY A SALES REPRESENTATIVE VIA PHONE THAT AN 0233-000 REAMER SHAFT EXPLODED (MULTIPLE PIECES) WHILE CONNECTED TO THE 0234-090 REAMER HEAD WHILE DRILLING THROUGH THE TIBIA. CASE INVOLVEMENT, DEVICE BROKE DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1317835 | FLEXIBLE REAMER SHAFT, NITINOL, HUDSON | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ARTHREX, INC. | FLEXIBLE REAMER SHAFT, NITINOL, HUDSON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |