MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-26 for SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE 4205000000 manufactured by Stryker Instruments-kalamazoo.
[5747780]
It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece is running in reverse while the safety switch is on. This event occurred during testing therefore, no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[5755766]
It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece is running in reverse while the safety switch is on. This event occurred during testing therefore, no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[13055425]
Device not returned to manufacturer for investigation. Customer has refused to return the device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[13329434]
The reported event, "the device still runs in reverse while safe is on", was not duplicated and no failures were confirmed as the device was not available for investigation. Device was not returned to the manufacturer facility for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01127 |
| MDR Report Key | 4634897 |
| Report Source | 07 |
| Date Received | 2015-03-26 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-04-21 |
| Device Manufacturer Date | 2005-11-28 |
| Date Added to Maude | 2015-03-26 |
| 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 | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| 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 | SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-03-26 |
| Catalog Number | 4205000000 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-26 |