MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-03 for STRYKER 4125-127-90 manufactured by Stryker Instruments.
[16718915]
(1069 break) during total knee procedure, a tooth broke off the saw blade - the staff was unaware at the time. This was discovered upon obtaining a post-cp x-ray in pacu. The saw blade was extracted from the biohazard waste receptal and examined. However, packaging info had already been compacted. No further intervention required surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002940 |
| MDR Report Key | 876278 |
| Date Received | 2007-07-03 |
| Date of Report | 2007-06-25 |
| Date of Event | 2007-06-20 |
| Date Added to Maude | 2007-09-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER |
| Generic Name | SAW BLADE / SAGITTAL |
| Product Code | DZH |
| Date Received | 2007-07-03 |
| Model Number | 4125-127-90 |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 889369 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILAM AVE. KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-03 |