FDA Adverse Event
Injury
Summary report: N
SMALL BATTERY DRIVE
MDR report key: 2890293
·
Received December 29, 2012
Report
- Report Number
- 8030965-2012-01701
- Event Type
- Injury
- Date Received
- December 29, 2012
- Date of Event
- October 3, 2012
- Report Date
- November 30, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RETURNED TO SYNTHES (B)(4), DATE UNKNOWN. SYNTHES (B)(4) RECEIVED THE DEVICE. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED. THE UNIT PASSED ALL OPERATIONAL SPECIFICATIONS AND NO PROBLEMS WERE OBSERVED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
DURING A VETERINARY HIP PROCEDURE, THE DEVICE WAS MAKING A GRINDING NOISE AND WAS NOT SPINNING. THE SURGERY WAS STOPPED BECAUSE THE USER DID NOT HAVE ANOTHER DRILL AVAILABLE FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMALL BATTERY DRIVE | SMALL BATTERY DRIVE | HTW | SYNTHES GMBH | 002873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |