FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER HANDLE REVOLVING TYPE
MDR report key: 3250782
·
Received July 29, 2013
Report
- Report Number
- 0008010177-2013-00174
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- June 12, 2013
- Report Date
- July 4, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION HENCE IT IS NOT POSSIBLE TO PERFORM THE PRODUCT SPECIFIC EXAMINATIONS AND THE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. HOWEVER, ACCORDING TO THE PROVIDED EMAIL IT WAS STATED PER SERVICE TECHNICIAN THAT THE DAMAGE OF THE PRODUCT WAS CAUSED DUE TO THE USE/MISUSE AT THE CUSTOMER SITE. DEVICE NOT RETURNED.
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
AS PER THE REPORTER SCREWDRIVER HANDLE WAS BROKEN DURING OPERATION.
Description of Event or Problem · 1
AS PER THE REPORTER SCREWDRIVER HANDLE WAS BROKEN DURING OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353327 | SCREWDRIVER HANDLE REVOLVING TYPE | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS-FREIBURG | 1000061669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |