FDA Adverse Event
Other
Summary report: N
SYNTHES DRILL BIT 3.2 MM-QUICK COUPLING
MDR report key: 78047
·
Received March 18, 1997
Report
- Report Number
- 1719045-1997-00002
- Event Type
- Other
- Date Received
- March 18, 1997
- Date of Event
- February 19, 1997
- Report Date
- March 18, 1997
- Manufacturer
- SYNTHES USA
- Product Code
- HTW
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
B1 ADVERSE EVENT SHOULD HAVE BEEN CHECKED. H1 SERIOUS INJURY SHOULD HAVE BEEN CHECKED. EVALUATION: THE ACTUAL DEVICE WAS EVALUATED BY AN INDEPENDENT METALLURGIST, MFR ENGINEER, AND CO'S PRODUCT DEVELOPMENT. MACROSCOPIC EXAMINATION, SCANNING ELECTRON MICROSCOPY, METALLOGRAPHIC EXAMINATION, AND HARDNESS TESTING WAS PERFORMED. BASES UPON THE TESTS AND EXAMINATION. THE DRILL BIT APPEARS TO BE THE RESULT OF MISHANDLING.
Description of Event or Problem · 1
DRILL BIT BROKE IN PT, PORTION REMAINS IN BONE IN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES DRILL BIT 3.2 MM-QUICK COUPLING | DRILL BIT | HTW | SYNTHES USA | NA | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |