FDA Adverse Event
Malfunction
Summary report: N
HOOK NARROW DEPTH GAUGE
MDR report key: 19635355
·
Received June 28, 2024
Report
- Report Number
- 3014128390-2024-00035
- 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
- UDI-DI
- 03701037316917
- 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 CANNULAS OF INSTRUMENTS 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 REAMER, A GLENOID IMPACTOR, AND A DEPTH GAUGE WERE FOUND TO HAVE DEBRIS INSIDE THEIR CANNULAS. A PHOTO AND VIDEO 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 |
|---|---|---|---|---|---|---|---|
| 2192400 | HOOK NARROW DEPTH GAUGE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | FX SHOULDER SOLUTIONS DALLAS | UNK | 03701037316917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | PART: 902-0900 LOT: UNK |