FDA Adverse Event
Malfunction
Summary report: N
T15 HEXALOBE, ISO, CANN.
MDR report key: 11947873
·
Received June 7, 2021
Report
- Report Number
- 1220246-2021-03231
- Event Type
- Malfunction
- Date Received
- June 7, 2021
- Date of Event
- May 18, 2021
- Report Date
- June 7, 2021
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867263765
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
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 · 1
IT WAS REPORTED DURING A CALCANEUS PROCEDURE, DURING INSERTION OF THE SCREW, THE TIP OF THE AR-8750-03, BROKE. THE BROKE PIECE WAS RETRIEVED USING FORCEPS AND A HEMOSTAT. THE ISSUE ADDED AN ADDITIONAL 15 MINUTES TO THE PROCEDURE REQUIRING ADDITIONAL ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849502 | T15 HEXALOBE, ISO, CANN. | PLATE, FIXATION, BONE | LXH | ARTHREX, INC. | T15 HEXALOBE, ISO, CANN. | 00888867263765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |