FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 19634262
·
Received June 28, 2024
Report
- Report Number
- 3014128390-2024-00034
- Event Type
- Malfunction
- Date Received
- June 28, 2024
- Date of Event
- June 17, 2024
- Report Date
- June 28, 2024
- Manufacturer
- FX SHOULDER SOLUTIONS DALLAS
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CONTAMINANT MATTER WAS DISCOVERED INSIDE THE CANNULA OF AN INSTRUMENT IN THE FIELD, AS THE PRODUCT WAS NOT SATISFACTORILY INSPECTED AND DECONTAMINATED. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 0
DURING SPD AT THE HOSPITAL BEFORE SURGERY, A K-WIRE WAS FOUND INSIDE A REAMER. THE K-WIRE WAS REMOVED AND FOUND TO BE CONTAMINATED WITH BLOOD AND TISSUE. A PHOTO WAS PROVIDED SHOWING THE ISSUE. NO SURGICAL DELAY WAS NOTED. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2206989 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | FX SHOULDER SOLUTIONS DALLAS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |