MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-10 for SYSTEM 5 SAGITTAL SAW 4208000000 manufactured by Stryker Instruments-kalamazoo.
[5350457]
It was reported by the customer that the device has something missing. Upon receiving at manufacturer facility it was found that the back screw is missing. The user facility was not able to provide any further information regarding the reported event.
Patient Sequence No: 1, Text Type: D, B5
[5638057]
It was reported by the customer that the device has something missing. Upon receiving at manufacturer facility, it was found that the back screw is missing. The user facility was not able to provide any further information regarding the reported event.
Patient Sequence No: 1, Text Type: D, B5
[12965579]
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed. Failure analysis is in progress.
Patient Sequence No: 1, Text Type: N, H10
[13211697]
The reported event of decorative nut missing was confirmed. All non-conforming parts were replaced along with other suggested components. Preventative maintenance was performed and the repaired handpiece was returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-00430 |
| MDR Report Key | 4502175 |
| Report Source | 06 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-01-13 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-04-02 |
| Device Manufacturer Date | 2011-09-09 |
| Date Added to Maude | 2015-02-10 |
| 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 | 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 | 2015-02-10 |
| Returned To Mfg | 2015-01-26 |
| 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 | 2015-02-10 |