FDA Adverse Event
Malfunction
Summary report: N
GALILEO® CAPTURING ROD
MDR report key: 23154870
·
Received September 26, 2025
Report
- Report Number
- 1220246-2025-04154
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 10, 2025
- Report Date
- January 2, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- HSB
- PMA / PMN Number
- K202099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 5033-100 BATCH 250013 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE THREADS WERE BROKEN/DAMAGED. A FUNCTIONAL TEST CANNOT BE PERFORMED DUE TO THE DEVICE'S DAMAGE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING MISALIGNED INSERTION OR EXCESSIVE FORCES THROUGH LEVERAGING/PRYING THE DEVICE.
Description of Event or Problem · 0
ON 09/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 5033-100 CAPTURING ROD IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2111864 | GALILEO® CAPTURING ROD | INTRAMED FIXATN ROD AND ACCESS | HSB | ARTHREX, INC. | GALILEO® CAPTURING ROD | 250013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |