MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-15 for UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS manufactured by Stryker Instruments-kalamazoo.
[4245153]
It was reported that during testing conducted at the manufacturer, a piece of broken blade was found in the handpiece. It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11599965]
Device was returned, evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[21657783]
It was reported that during testing conducted at the manufacturer that a piece of broken blade was found in the handpiece. It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[22088124]
The device is available for return. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-00177 |
| MDR Report Key | 3576702 |
| Report Source | 07 |
| Date Received | 2014-01-15 |
| Date of Report | 2013-12-18 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2014-01-15 |
| 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 | UNKNOWN_INSTRUMENTS_PRODUCT |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2014-01-15 |
| Returned To Mfg | 2013-12-16 |
| Catalog Number | UNK_INS |
| Operator | OTHER |
| 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 | 940000000 | 2014-01-15 |