FDA Adverse Event
Malfunction
Summary report: N
CANNULATED SCREW ASNIS III 6.5X75MM
MDR report key: 2112229
·
Received April 29, 2011
Report
- Report Number
- 8031020-2011-00088
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 12, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- PMA / PMN Number
- K000080
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. PACKAGING WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, FOR AN ANKLE SURGERY, THE SCREW CADDY WHERE THEY KEEP THE SCREWS STERILE WAS USED FOR THE CASE PRIOR TO THIS ONE. EXPIRED IMPLANT/SCREWS WERE OPENED BY THE HOSPITAL STAFF TO AVOID RESCHEDULING SURGERY BECAUSE THE PATIENT WAS ALREADY IN THE OPERATING ROOM PREPPED FOR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED SCREW ASNIS III 6.5X75MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | M05889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |