MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-21 for TITANIUM NITRIDED BLADE 0940035000 manufactured by Stryker Instruments-kalamazoo.
[6032281]
It was reported that the blade went dull after removing 3 casts. It was also reported that when trying to remove the fourth cast, it was noted that the teeth on the blade were worn down. It was also reported there were no adverse consequences as a result of this event, the procedure was completed successfully without delay.
Patient Sequence No: 1, Text Type: D, B5
[14033379]
A follow up report will be filed once the quality investigation is complete. Device not yet returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[37061317]
A dhr (device history record) review of the manufacturing data during the manufacture of this blade indicated that the blade met all manufacturing specifications. Measurements performed on the returned blade against part print specification indicated that the blade met all measurements performed.
Patient Sequence No: 1, Text Type: N, H10
[37061318]
It was reported that the blade went dull after removing 3 casts. It was also reported that when trying to remove the fourth cast, it was noted that the teeth on the blade were worn down. It was also reported there were no adverse consequences as a result of this event, the procedure was completed successfully without delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-02631 |
| MDR Report Key | 4927109 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-24 |
| Date Mfgr Received | 2016-01-21 |
| Device Manufacturer Date | 2015-05-20 |
| Date Added to Maude | 2015-07-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2015-07-21 |
| Returned To Mfg | 2015-10-20 |
| Catalog Number | 0940035000 |
| Lot Number | 15140017 |
| 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 | 2015-07-21 |