FDA Adverse Event
Injury
Summary report: N
SUPERMX COMPRESSION STAPLE, 20W X 20L
MDR report key: 19448121
·
Received June 3, 2024
Report
- Report Number
- 1220246-2024-04724
- Event Type
- Injury
- Date Received
- June 3, 2024
- Date of Event
- May 5, 2022
- Report Date
- June 3, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- JDR
- UDI-DI
- 00888867300965
- PMA / PMN Number
- K203180
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT AFTER THE DEVICE WAS IMPLANTED INTO A PATIENT IT WAS FOUND THAT ONE LEG OF THE STAPLE HAS BROKEN HALF WAY DOWN. THE PATIENT HAS NO ISSUES AND THE JOUNT HAS SUCCESSFULLY FUSED. NO FURTHER INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1838792 | SUPERMX COMPRESSION STAPLE, 20W X 20L | STAPLE, FIXATION, BONE | JDR | ARTHREX, INC. | SUPERMX COMPRESSION STAPLE, 20W X 20L | UNK | 00888867300965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |