FDA Adverse Event
Malfunction
Summary report: N
WRKST BUSHING ALOGFT OATS,22.5MM
MDR report key: 19475202
·
Received June 6, 2024
Report
- Report Number
- 1220246-2024-05021
- Event Type
- Malfunction
- Date Received
- June 6, 2024
- Date of Event
- May 9, 2024
- Report Date
- September 19, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867032279
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-4081-22 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED DISCOLORATION SPOTS, FADED LASER MARKS. SCRATCHES OUTSIDE AND INSIDE THE DIAMETER THE REPORTED FAILURE MAY BE DUE TO WEAR AND TEAR FROM PROLONGED USE IN THE FIELD, AS THE DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR AND TEAR.
Description of Event or Problem · 0
ON 05/09/2024 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-4081-225 ALLOGRAFT OATS BUSHING IS PRODUCING DEBRIS WHEN IN USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1688459 | WRKST BUSHING ALOGFT OATS,22.5MM | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | ALLOGRAFT OATS WORKSTATION BUSHING 22MM | UNK | 00888867032279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |