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 2015-03-05 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.
[5549440]
It was reported that the device is not working properly during a procedure at user facility. There was a delay of unknown length. Additional information has been requested from the user facility. It was found during service inspection that there is water inside the handpiece.
Patient Sequence No: 1, Text Type: D, B5
[13022625]
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[24439654]
Device was repaired and returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10
[24439655]
It was reported that the device is not working properly during a procedure at user facility. There was a delay of unknown length. Additional information has been requested from the user facility. It was found during service inspection that there is water inside the handpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-00788 |
| MDR Report Key | 4572846 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-05 |
| Date of Event | 2015-02-03 |
| Date Mfgr Received | 2015-08-28 |
| Device Manufacturer Date | 2007-02-14 |
| Date Added to Maude | 2015-03-05 |
| 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 | 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 | 2015-03-05 |
| Catalog Number | 4208000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-03-05 |