MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-09 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Instruments-kalamazoo.
[51497676]
A partial blade was returned for evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[51497677]
It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[70195826]
Investigation results concluded that misloading of the device was a contributing factor to the fracture of the blade. The ifu for devices associated with the blade state the following "before operating the equipment, always make sure the blade is securely installed and the blade retention screw is tight. An improperly tightened screw may come loose and cause the blade to fracture".
Patient Sequence No: 1, Text Type: N, H10
[70195827]
It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-01753 |
| MDR Report Key | 5857237 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-09 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2016-08-09 |
| 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. UNA BARRY |
| 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 | 2016-08-09 |
| Returned To Mfg | 2016-08-02 |
| Catalog Number | 0940023000 |
| 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 | 2016-08-09 |