FDA Adverse Event
Malfunction
Summary report: N
24MM PRIMARY REAMER
MDR report key: 21001068
·
Received December 23, 2024
Report
- Report Number
- 1220246-2024-09022
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- November 27, 2024
- Report Date
- July 10, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, 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: G3, H3, H6 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 IS WEAR AND TEAR INCURRED OVER REPEATED USE.
Description of Event or Problem · 0
ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9620-30D DRILL HAD BONE STUCK IN IT AND WAS UNABLE TO BE USED. AND AN AR-9618-24, AND AR-9618-24 REAMER ARE DULL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79645 | 24MM PRIMARY REAMER | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | 24MM PRIMARY REAMER | 021937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |