FDA Adverse Event
Malfunction
Summary report: N
BIO INSTABILITY DRILL BIT 2.1MM
MDR report key: 782803
·
Received November 13, 2006
Report
- Report Number
- 1017294-2006-00458
- Event Type
- Malfunction
- Date Received
- November 13, 2006
- Report Date
- October 20, 2006
- Manufacturer
- COMMED LINVATEC
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: THE DRILL BIT WAS RECEIVED FOR EVAL. A VISUAL EXAMINATION OF THE DEVICE FOUND GALLING AT THE DISTAL END OF THE DRILL BIT. A REVIEW OF HISTORY FOR THIS PRODUCT FOUND ONE OTHER SIMILAR REPORTED EVENT. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING USE OF THE DRILL BIT IN A SHOULDER ARTHROSCOPY, METAL SHAVINGS WERE OBSERVED IN THE JOINT. IT IS NOT KNOWN IF ALL METAL SHAVINGS WERE RETRIEVED. TO DATE, THE PT IS DOING FINE AND NO ADDITIONAL TREATMENT IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO INSTABILITY DRILL BIT 2.1MM | DRILL BIT | HTW | COMMED LINVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | CATALOG#: C6172, BIOSTABILITY DRILL GUIDE SERRATED |