FDA Adverse Event
Malfunction
Summary report: N
DILATOR, 4.1 X 220MM
MDR report key: 20557450
·
Received October 29, 2024
Report
- Report Number
- 1220246-2024-08297
- Event Type
- Malfunction
- Date Received
- October 29, 2024
- Date of Event
- October 11, 2024
- Report Date
- July 8, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- HNW
- UDI-DI
- 00888867462021
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.
Description of Event or Problem · 0
ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-S6524-041-220, AR-S6524-051-210, AR-S6524-060-200, AND AR-S6524-071-190 DILATOR IS CHIPPED AND BENT AFTER REPEATED USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 923749 | DILATOR, 4.1 X 220MM | DILATOR | HNW | ARTHREX, INC. | DILATOR, 4.1 X 220MM | 01582604 | 00888867462021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |