FDA Adverse Event
Malfunction
Summary report: N
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
MDR report key: 1210025
·
Received October 21, 2008
Report
- Report Number
- 1719045-2008-00143
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HTO
- PMA / PMN Number
- K013527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
WHILE ATTEMPTING TO REAM, THE CANAL WAS TIGHT, SURGEON BROUGHT REAMER BACK AND FORTH AND ON THIRD ATTEMPT THE REAMER HEAD BROKE OFF IN THE CANAL. RETRIEVED REAMER HEAD WITH A BALL TIP GUIDE, HOWEVER, TWO SMALL DEVICE FRAGMENTS WERE NOT RETRIEVED. RETAINED FRAGMENTS MAY BE THOSE OF REAMER DRIVE SHAFT OR REAMER HEAD; THIS IS ONE OF TWO REPORTS SUBMITTED FOR ONE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA | REAMER DRIVE SHAFT | HTO | SYNTHES (USA) | NA | 15175-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | REAMER HEAD |