MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-16 for MICRO OSCILLATING SAW 5400031000 manufactured by Stryker Instruments Kalamazoo.
[1779368]
It was reported that the handpiece was running on its own while being tested. This did not occur during a surgical procedure. There was no patient involvement or any adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8846773]
The handpiece was received at the manufacturer for evaluation, and the reported condition of the device running on its own was duplicated. Based on the investigation details, the likely cause was problems with the motor, press plug, and bearings, which were each replaced along with other components. Service did a clean, lube, and adjust to the device, and it was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2010-02051 |
| MDR Report Key | 1960749 |
| Report Source | 07 |
| Date Received | 2010-12-16 |
| Date of Report | 2010-11-24 |
| Date of Event | 2010-11-23 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2007-10-25 |
| Date Added to Maude | 2011-02-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREGORY GOHL |
| 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 OSCILLATING SAW |
| Generic Name | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC |
| Product Code | DZH |
| Date Received | 2010-12-16 |
| Returned To Mfg | 2010-11-29 |
| Catalog Number | 5400031000 |
| Operator | OTHER |
| 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 | 2010-12-16 |