MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-11 for SYNTHES CHUCK 4103110000 manufactured by Stryker Instruments-kalamazoo.
[5440329]
It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the blue ring is missing from the attachment. There was 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
[12885524]
The reported event, missing blue ring, was confirmed. Due to the age of the device, it is possible that cleaning may have contributed to the failure or the device may have been subjected to a direct hit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-00483 |
| MDR Report Key | 4508912 |
| Report Source | 06 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-01-15 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2015-01-15 |
| Device Manufacturer Date | 2005-09-30 |
| Date Added to Maude | 2015-02-11 |
| 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 | 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 | SYNTHES CHUCK |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-02-11 |
| Returned To Mfg | 2015-01-21 |
| Catalog Number | 4103110000 |
| Operator | OTHER |
| Device Availability | R |
| 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 | 2015-02-11 |