FDA Adverse Event
Malfunction
Summary report: N
HUMELOCK II
MDR report key: 20482060
·
Received October 18, 2024
Report
- Report Number
- 3014128390-2024-00056
- Event Type
- Malfunction
- Date Received
- October 18, 2024
- Date of Event
- September 25, 2024
- Report Date
- October 18, 2024
- Manufacturer
- FX SHOULDER SOLUTIONS DALLAS
- Product Code
- HSD
- UDI-DI
- 03701037300510
- PMA / PMN Number
- K111097
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
WALL OF PLASTIC TRAY WAS DAMAGED, COMPROMISING THE SEAL. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 0
DURING SURGICAL PREPARATION, A 50X20 OFFSET HEAD WAS OPENED AND IT WAS SEEN THAT THE SIDE WALL OF THE PLASTIC TRAY WAS DAMAGED, BREAKING THE PRIMARY STERILE BARRIER. THE WHITE OUTER BOX WAS UNDAMAGED AND DID NOT SHOW ANY SIGNS OF THE CONTAINED DEFECT. NO SURGICAL DELAY NOTED. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2230838 | HUMELOCK II | PROSETHSIS, SHOULDER | HSD | FX SHOULDER SOLUTIONS DALLAS | S0191 | 03701037300510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |