FDA Adverse Event
Malfunction
Summary report: N
DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS
MDR report key: 3135244
·
Received May 29, 2013
Report
- Report Number
- 8030965-2013-02380
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- K043310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES AND COMMON DEVICE NAMES: DZI - DRILL, BONE, POWERED; ERL - DRILL, SURGICAL, ENT, HANDPIECE; HBE - DRILLS, BURRS, TREPHINES AND ACCESSORIES. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
DISTRIBUTOR REPORTS DURING A MOLAR EXTRACTION PROCEDURE, THE BURR ATTACHMENT WOULD NOT SECURE INTO THE DRILL AND THE BEARING IN THE FRONT IS LOOSE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236950 | DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS | INSTRU, SURGICAL, ORTHOPEDIC,AC, POWERED | HWE | SYNTHES GMBH | 1452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |