FDA Adverse Event
Malfunction
Summary report: N
COMPRESSED AIR MOTOR
MDR report key: 3010176
·
Received March 19, 2013
Report
- Report Number
- 8030965-2013-00971
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- February 21, 2013
- Report Date
- February 22, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
THE USER FACILITY REQUESTED A REPAIR OF THE COMPRESSED AIR MOTOR. REPORTEDLY, THE COMPRESSED AIR MOTOR WENT DOWN DURING A WRIST ARTHROSCOPY PROCEDURE. WHEN THE COMPRESSED AIR MOTOR WAS TESTED IN THE STERILE FIELD, IT WAS NOTED THAT AIR WAS NOT GOING THROUGH THE HANDLE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114045 | COMPRESSED AIR MOTOR | HWE | SYNTHES GMBH | 7039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |