MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-29 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.
[5184989]
It was reported that the handpiece was leaking a green fluid after being submerged in sterile water during a procedure at user facility. The liquid did not come in contact with the sterile field. The procedure was completed successfully using back-up equipment. No delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[12773790]
The reported event, green liquid came out of the device, was not duplicated. Based on review of the ifu, it was advised that the handpiece should not be immersed. Based on the information provided in the event description of the device being submerged, this could cause liquid to run out of the handpiece. Preventative maintenance was performed and the repaired handpiece was returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-00328 |
| MDR Report Key | 4463367 |
| Report Source | 06 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-02 |
| Date of Event | 2015-01-02 |
| Date Mfgr Received | 2015-01-02 |
| Device Manufacturer Date | 2006-05-18 |
| Date Added to Maude | 2015-01-29 |
| 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 | SYSTEM 5 SAGITTAL SAW |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-01-29 |
| Returned To Mfg | 2015-01-13 |
| Catalog Number | 4208000000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-01-29 |