FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE HUMERAL HEAD EXTRACTOR
MDR report key: 20733570
·
Received November 20, 2024
Report
- Report Number
- 1220246-2024-08569
- Event Type
- Malfunction
- Date Received
- November 20, 2024
- Date of Event
- October 29, 2024
- Report Date
- July 8, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- MDM
- UDI-DI
- 00888867060333
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.
Description of Event or Problem · 0
ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9401-17 ARTHREX ECLIPSE¿ DURING A CASE THE HUMERAL HEAD EXTRACTOR BROKE WHILE TRYING TO MALLET IT INTO THE REVISION BUT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2430843 | ECLIPSE HUMERAL HEAD EXTRACTOR | MANUAL INSTR, GENERAL SURGICAL | MDM | ARTHREX, INC. | ECLIPSE HUMERAL HEAD EXTRACTOR | UNK | 00888867060333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |