MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-11 for REPROCESSED STRYKER STERNUM SAW BLADE 298-97-100 manufactured by Sterilmed, Inc..
[770130]
A reprocessed sternum saw blade broke into 2 pieces during use.
Patient Sequence No: 1, Text Type: D, B5
[7898730]
Limited information about the event was provided by the user facility. 100% of like devices are inspected by sterilmed. The device in question was sharpened and passed all sterilmed inspection criteria. It is possible this malfunction may result when excessive force or torque is applied to the blade during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2007-00017 |
| MDR Report Key | 964925 |
| Report Source | 06 |
| Date Received | 2007-12-11 |
| Date of Report | 2007-12-11 |
| Date of Event | 2007-11-29 |
| Date Mfgr Received | 2007-11-16 |
| Device Manufacturer Date | 2007-08-31 |
| Date Added to Maude | 2008-03-28 |
| 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 | DENNIS TOUSSAINT |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED STRYKER STERNUM SAW BLADE |
| Generic Name | REPROCESSED SAW BLADE |
| Product Code | DZH |
| Date Received | 2007-12-11 |
| Returned To Mfg | 2007-12-06 |
| Model Number | 298-97-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 971170 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-11 |