FDA Adverse Event
Malfunction
Summary report: N
3.0MM HEX DRIVER
MDR report key: 23031964
·
Received September 11, 2025
Report
- Report Number
- 1220246-2025-03820
- Event Type
- Malfunction
- Date Received
- September 11, 2025
- Date of Event
- August 22, 2025
- Report Date
- November 7, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H3, H6. - ONE UNPACKAGED, AR-9625, 3.0 MM HEX DRIVER, BATCH 022030, WAS RECEIVED FOR EVALUATION. - VISUAL INSPECTION NOTED A BROKEN HEX DISTAL TIP. - FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. - THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO PRYING/LEVERAGING THE DEVICE DURING INSERTION. - REFER TO INVESTIGATION PHOTOS. - COMPLAINT ALLEGATION IS CONFIRMED.
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem · 0
ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9625 HEX DRIVER TIP BROKE OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2232168 | 3.0MM HEX DRIVER | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | 3.0MM HEX DRIVER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |