FDA Adverse Event
Injury
Summary report: N
DRIVER SHAFT, T8 HEXALOBE, CANNULATED
MDR report key: 15534025
·
Received October 3, 2022
Report
- Report Number
- 1220246-2022-05556
- Event Type
- Injury
- Date Received
- October 3, 2022
- Date of Event
- September 15, 2022
- Report Date
- October 3, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867046108
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED ON 09/15/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR- 8737-15 DRIVER HEAD BENT AND THE SCREW HAD TO BE BURRED OUT OF THE BONE. THIS OCCURRED DURING A CASE AND THE SURGEON DEVIATED FROM THE INTENDED PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2935664 | DRIVER SHAFT, T8 HEXALOBE, CANNULATED | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | DRIVER SHAFT, T8 HEXALOBE, CANNULATED | 4751508 | 00888867046108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |