MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-14 for TITANIUM NITRIDED BLADE 0940035000 manufactured by Stryker Instruments-kalamazoo.
[22940471]
The device is available for return. A follow up report will be filed once the quality investigation is complete. Device not yet returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[22940472]
It was reported that the blade went dull when used to cut a cast for the first time. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[32659876]
It was initially reported that the blade was available for return to the manufacturer. It has since been reported that the blade was discarded by the customer. The quality investigation is complete. Blade scrapped by the customer.
Patient Sequence No: 1, Text Type: N, H10
[32659877]
It was reported that the blade went dull when used to cut a cast for the first time. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-02917 |
| MDR Report Key | 5002965 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-12-02 |
| Date Added to Maude | 2015-08-14 |
| 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 | 3 |
| Event Location | 3 |
| 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 | TITANIUM NITRIDED BLADE |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2015-08-14 |
| Catalog Number | 0940035000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-08-14 |