MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-01-21 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.
[5390628]
It was reported that during preparation for a surgical procedure conducted at the user facility the device was unintentionally running when the battery was connected. 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
[12763759]
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[23921891]
The reported event was confirmed by a manufacturer repair technician through functional evaluation. Upon disassembly, it was found several components needed to be replaced, including the carriage return, which can lead to the reported event. As requested by the user facility, the device was returned unrepaired.
Patient Sequence No: 1, Text Type: N, H10
[23921892]
It was reported that during preparation for a surgical procedure conducted at the user facility the device was unintentionally running when the battery was connected. 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
| Report Number | 0001811755-2015-00242 |
| MDR Report Key | 4439383 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-01-21 |
| Date of Report | 2014-12-26 |
| Date of Event | 2014-12-24 |
| Date Mfgr Received | 2015-08-24 |
| Device Manufacturer Date | 2009-01-13 |
| Date Added to Maude | 2015-01-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 SAGITTAL SAW |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-01-21 |
| Catalog Number | 4208000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-01-21 |