FDA Adverse Event
Malfunction
Summary report: N
SET SCREW, RECON
MDR report key: 2666707
·
Received July 17, 2012
Report
- Report Number
- 9610622-2012-00303
- Event Type
- Malfunction
- Date Received
- July 17, 2012
- Date of Event
- June 24, 2012
- Report Date
- June 26, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS ¿ KIEL
- Product Code
- HSB
- PMA / PMN Number
- K051624
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. DEVICE WAS LOST DURING DECONTAMINATION. IF ADD'L INFO IS RECEIVED, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "AFTER IMPLANTING T2 RECON NAIL AND BOTH (2) T2 RECON LAG SCREWS SURGEON ATTEMPTED TO IMPLANT T2 RECON SET SCREW. WHILE TRYING TO IMPLANT PLASTIC TIP OF SET SCREW FELL OFF. OPENED SECOND SET SCREW AND SAME THING HAPPED-PLASTIC TIP OF SET SCREW FELL OFF. SURGEON WAS UNABLE TO USE SET SCREW. ADDED ABOUT 45 MINUTES TO CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREW, RECON | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS ¿ KIEL | NA | K515352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |