FDA Adverse Event
Malfunction
Summary report: N
TENODESIS SCREW, BIOCOMPOSITE
MDR report key: 14603391
·
Received June 6, 2022
Report
- Report Number
- 1220246-2022-05035
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Date of Event
- May 16, 2022
- Report Date
- June 6, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWC
- UDI-DI
- 00888867018853
- PMA / PMN Number
- K051726
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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.
Description of Event or Problem · 0
ON 5/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1555BC BIOCOMPOSITE-TENODESIS SCREW BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED AND A SECOND BIOCOMPOSITE-TENODESIS SCREW WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN FHL TRANSFER ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2367034 | TENODESIS SCREW, BIOCOMPOSITE | SCREW, FIXATION, BONE | HWC | ARTHREX, INC. | TENODESIS SCREW, BIOCOMPOSITE | 11805296 | 00888867018853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |