MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-08-19 for MICRO SAGITTAL SAW 5400034000 manufactured by Stryker Instruments Kalamazoo.
[1233238]
It was reported by the customer that the handpiece was leaking oil from the blade mount area. At the time of the observation, the handpiece had not been used in a procedure. No patient involvement. There were no reports of any adverse patient event associated with this malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8477712]
The handpiece involved in the reported event was evaluated. During the evaluation, the technician noted the handpiece was leaking black fluid. The handpiece was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2009-00404 |
| MDR Report Key | 1470936 |
| Report Source | 06 |
| Date Received | 2009-08-19 |
| Date of Report | 2009-07-21 |
| Date of Event | 2009-07-07 |
| Date Mfgr Received | 2009-07-21 |
| Device Manufacturer Date | 2005-01-12 |
| Date Added to Maude | 2009-12-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARVIN POWELL |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO SAGITTAL SAW |
| Generic Name | BONE CUTTING INSTRUMENTS AND ACCESSORIES |
| Product Code | DWI |
| Date Received | 2009-08-19 |
| Returned To Mfg | 2009-07-21 |
| Model Number | NA |
| Catalog Number | 5400034000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-19 |