FDA Adverse Event
Malfunction
Summary report: N
SHORT GUIDE PIN
MDR report key: 2868273
·
Received December 7, 2012
Report
- Report Number
- 3004154314-2012-00005
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- April 9, 2012
- Report Date
- December 5, 2012
- Manufacturer
- ARTHROSURFACE, INC.
- Product Code
- LXH
- PMA / PMN Number
- K017413
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS INITIALLY INTERPRETED PER 21 CFR.806 TO NOT BE REPORTABLE. DUE TO DISCUSSION IN A RECENT FDA AUDIT, A SIMILAR INCIDENT WAS REPORTED AND THUS THIS MDR IS INCLUDED AS WELL.
Description of Event or Problem · 1
IN AN ARTHROSURFACE PATELLO-FEMORAL XL IMPLANT SURGERY, A GUIDE PIN BROKE AND THE PIN TIP WAS NOT RETRIEVED. THE PIN REMAINED IN THE PATIENT AND NOT ISSUES WERE NOTED. THE PIN IS MADE OF 316 LVM SST PER ASTM F138 WHICH IS AN IMPLANTABLE GRADE MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHORT GUIDE PIN | NONE | LXH | ARTHROSURFACE, INC. | 2007-1510 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |