FDA Adverse Event
Malfunction
Summary report: N
T10 HEXALOBE, CMP FT
MDR report key: 16808724
·
Received April 25, 2023
Report
- Report Number
- 1220246-2023-06580
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- March 27, 2023
- Report Date
- April 25, 2023
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867127166
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-8737-38 DRIVER SHAFT, T10 HEX, SERIAL/BATCH NUMBER 1392116, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DEVICE¿S HEX TIP HAD BROKEN OFF AND WAS BENT. NO FUNCTIONAL TESTING WAS PERFORMED FOR THIS DEVICE DUE TO THE BROKEN TIP. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.
Description of Event or Problem · 0
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-8737-38 DRIVER SHAFTS BROKE. THIS OCCURRED DURING A TTO CASE ON (B)(6)2023, THE CASE WAS COMPLETED USING A DEVICE FROM A DIFFERENT MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091633 | T10 HEXALOBE, CMP FT | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T10 HEXALOBE, CMP FT | 1392116 | 00888867127166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |