MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-12 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.
[31009123]
It was reported that in the central sterile department of the user facility after a surgical procedure at the user facility, a screw had fallen out of the device, posing the risk of a small component being lost in a surgical site. The procedure was completed successfully, and there was no surgical delay. The patient was given an x-ray, and no screw was observed. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[32199884]
The service technician observed the decorative screw was missing.
Patient Sequence No: 1, Text Type: N, H10
[32199885]
It was reported that in the central sterile department of the user facility after a surgical procedure at the user facility, a screw had fallen out of the device, posing the risk of a small component being lost in a surgical site. The procedure was completed successfully, and there was no surgical delay. The patient was given an x-ray, and no screw was observed. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-04122 |
| MDR Report Key | 5220190 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-12 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-11-19 |
| Device Manufacturer Date | 2007-02-27 |
| Date Added to Maude | 2015-11-12 |
| 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 | 2015-11-12 |
| Returned To Mfg | 2015-10-27 |
| Catalog Number | 4208000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2015-11-12 |