FDA Adverse Event
Malfunction
Summary report: N
DRV SFT,T15 HEXALOBE,CANN,STR
MDR report key: 14136948
·
Received April 18, 2022
Report
- Report Number
- 1220246-2022-04763
- Event Type
- Malfunction
- Date Received
- April 18, 2022
- Date of Event
- March 31, 2022
- Report Date
- April 18, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867046221
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8737-27 SCREW DRIVER BROKE WHILE DRIVING A 3.5 SCREW. THIS WAS DISCOVERED DURING A CASE AND BROKE DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 923517 | DRV SFT,T15 HEXALOBE,CANN,STR | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | DRV SFT,T15 HEXALOBE,CANN,STR | 4751344 | 00888867046221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |