FDA Adverse Event
Malfunction
Summary report: N
CORTICAL BONE SCREW, Ø3.5MM X 35MM
MDR report key: 15534190
·
Received October 3, 2022
Report
- Report Number
- 1220246-2022-05551
- Event Type
- Malfunction
- Date Received
- October 3, 2022
- Date of Event
- September 16, 2022
- Report Date
- October 3, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- HSB
- UDI-DI
- 00848665034110
- PMA / PMN Number
- K132005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, 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)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO 8110-035 CORTICAL SCREWS BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2930769 | CORTICAL BONE SCREW, Ø3.5MM X 35MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ARTHREX, INC. | CORTICAL BONE SCREW, Ø3.5MM X 35MM | 00848665034110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |