FDA Adverse Event
Malfunction
Summary report: N
2.9MM BIOCOMPOSITE PUSHLOCK KIT
MDR report key: 19190393
·
Received April 26, 2024
Report
- Report Number
- 1220246-2024-02426
- Event Type
- Malfunction
- Date Received
- April 26, 2024
- Date of Event
- July 22, 2021
- Report Date
- April 26, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- MAI
- UDI-DI
- 00888867224117
- PMA / PMN Number
- K101679
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED, THE DEVICE WAS RETURNED WITHOUT A TEMPERATURE STICKER. AN NCR WAS OPENED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE AR-2923BC-K, INDICATOR LABEL IS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2127514 | 2.9MM BIOCOMPOSITE PUSHLOCK KIT | BIO SOFT TISSUE FIXATN FASTNR | MAI | ARTHREX, INC. | 2.9MM BIOCOMPOSITE PUSHLOCK KIT | 13575552 | 00888867224117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |