MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2014-03-19 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Instruments-kalamazoo.
[4296578]
It was reported that during a cast removal the cast cutter blade broke. A delay of 15 minutes was reported as a result of this event whilst a back up device was retrieved. No patient impact or adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[11572401]
Device has been returned to the manufacturer. An evaluation is expected to be completed, a follow up report will be submitted upon completion of this evaluation.
Patient Sequence No: 1, Text Type: N, H10
[16551516]
It was reported that during a cast removal, the cast cutter blade broke. A delay of 15 minutes was reported as a result of this event whilst a back up device was retrieved. No patient impact or adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[16774516]
Evaluation of returned device complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-00943 |
| MDR Report Key | 3687630 |
| Report Source | 00,06 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-04-16 |
| Device Manufacturer Date | 2011-12-02 |
| Date Added to Maude | 2014-03-19 |
| 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 | ION NITRIDED BLADE |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-P |
| Product Code | LGH |
| Date Received | 2014-03-19 |
| Returned To Mfg | 2014-03-18 |
| Catalog Number | 0940023000 |
| Lot Number | 11336017 |
| 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 | 2014-03-19 |