MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-23 for STAINLESS STEEL BLADE 0840040250 manufactured by Stryker Instruments-kalamazoo.
[4703300]
It was reported that the blade broke after being used 10 times. There were no adverse consequences or surgical delay reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[5733596]
It was reported initially reported that the blade broke after being used 10 times. It was subsequently reported that the blade was blunt. There were no adverse consequences or surgical delay reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12178716]
The device return has been requested. A follow up report will be filed once the quality investigation is complete. Device not yet made available for return.
Patient Sequence No: 1, Text Type: N, H10
[13278126]
The cast cutter blade associated with this event was returned to the manufacturer for evaluation. It was visually confirmed there was no excessive wear on the teeth that all teeth were intact. Follow up information received confirmed that the cast cutter was being used to cut synthetic material. The ifu (instructions for use) for the cast cutter blade cautions the user that the stainless steel cast cutter blades are not recommended for use with synthetic material. The use of this cast cutter blade with synthetic material may have made the blade appear to be dull when in use with such cutting material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-03342 |
| MDR Report Key | 4111802 |
| Report Source | 06 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-08-28 |
| Date of Event | 2014-08-28 |
| Date Mfgr Received | 2015-04-02 |
| Device Manufacturer Date | 2014-06-17 |
| Date Added to Maude | 2014-09-23 |
| 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. DERVILLIA MURPHY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAINLESS STEEL BLADE |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2014-09-23 |
| Returned To Mfg | 2014-11-04 |
| Catalog Number | 0840040250 |
| Lot Number | 14168017 |
| 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 | 2014-09-23 |