FDA Adverse Event
Injury
Summary report: N
G-WIRE W/TRCR TIP, THDD, 062"X9.25"
MDR report key: 9756800
·
Received February 26, 2020
Report
- Report Number
- 1220246-2020-01734
- Event Type
- Injury
- Date Received
- February 26, 2020
- Date of Event
- February 12, 2020
- Report Date
- February 26, 2020
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867263642
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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.
Description of Event or Problem · 1
IT WAS REPORTED DURING A LAPIDUS FUSION AND A MEDIALIZING CALCANEAL OSTEOTOMY PROCEDURE THE TIPS OF THE AR-8737-42 GUIDE WIRE TROCAR TIP WITH LASER LINE, AND AR-8750KT GUIDE WIRE WITH TROCAR TIP BROKE OFF WHERE THE THREADS START. THE REP REPORTED THE BROKEN TIPS WERE SO SMALL THAT THEY COULD NOT BE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217720 | G-WIRE W/TRCR TIP, THDD, 062"X9.25" | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | G-WIRE W/TRCR TIP, THDD, 062"X9.25" | 00888867263642 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |