FDA Adverse Event
Malfunction
Summary report: N
REPAIR MAESTRO DRILL
MDR report key: 1970381
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00178
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 28, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR, HOWEVER THE INVESTIGATION HAS NOT BEGUN. THE USER FACILITY REPORTED THAT THE DRILL'S HOSE BECAME CAUGHT ON A TABLE AND WAS TORN. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REVEAL ANY ADD'L INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HOSE PORTION OF THE PNEUMATIC DRILL WAS TORN. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A DELAY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR MAESTRO DRILL | MOTOR, DRILL, PNEUMATIC | HBB | STRYKER INSTRUMENTS KALAMAZOO | 0912411213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |