MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-10 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Instruments-kalamazoo.
[40067669]
A follow up report will be filed once the quality investigation is complete. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[40067670]
It was reported that when the nurse was removing the cast on the forearm, the patient received 2 cuts that were 1. 5cms to 2. 0cms long and started to bleed. It was also reported that the wounds were put together and the patient received wound dressings. It was further reported that there was no infection as a result of this event and no additional treatment is expected.
Patient Sequence No: 1, Text Type: D, B5
[48040093]
The cast cutter blade and the concomitant cast cutter ((b)(4)) reported involved with this event were returned for evaluation. Measurements performed on the returned blade against part print specification indicated that the blade met all measurements performed. Investigation results for both the cast cutter and the blade indicate the reported failure could not be confirmed. The definitive root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[48040094]
It was reported that when the nurse was removing the cast on the forearm, the patient received 2 cuts that were 1. 5cms to 2. 0cms long and started to bleed. It was also reported that the wounds were put together and the patient received wound dressings. It was further reported that there was no infection as a result of this event and no additional treatment is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-00282 |
| MDR Report Key | 5492356 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-10 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-05-24 |
| Date Added to Maude | 2016-03-10 |
| 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 | ION NITRIDED BLADE |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2016-03-10 |
| Returned To Mfg | 2016-03-15 |
| Catalog Number | 0940023000 |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2016-03-10 |