FDA Adverse Event
Malfunction
Summary report: N
LUHR O/SET SCR/DRI 90 DEG
MDR report key: 113507
·
Received August 11, 1997
Report
- Report Number
- 9610622-1997-00072
- Event Type
- Malfunction
- Date Received
- August 11, 1997
- Report Date
- August 8, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: EVALUATIONS RESULTS RECEIVED FROM HOWMEDICA GMBH, IN KIELS, GERMANY, INDICATE THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE RELATED TO IMPROPER CLEANING METHODS USED BY CUSTOMER.
Description of Event or Problem · 1
THE SCREWDRIVER MECHANISM WOULD NOT TURN. THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE TO THE PT OR SURGICAL DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUHR O/SET SCR/DRI 90 DEG | INSTRUMENT | HXX | HOWMEDICA INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |