MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-17 for UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS manufactured by Stryker Instruments-kalamazoo.
[20978475]
It was reported that during cast removal procedure, the screw that holds the blade guard was stripped. It was subsequently noted that on return of the device to the manufacturer, the cast cutter blade was broken. It was also reported that there were no delays, no medical intervention and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[21296816]
Device returned, evaluation completed.
Patient Sequence No: 1, Text Type: N, H10
[22003949]
It was reported that cast removal procedure the screw that holds the blade guard, was stripped. It was subsequently noted that on return of the device to the manufacturer, the cast cutter blade was broken. It was also reported that there were no delays, no medical intervention and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[22304636]
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 | 0001811755-2013-03273 |
| MDR Report Key | 3523535 |
| Report Source | 06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-18 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2013-12-17 |
| 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 | 2013-12-17 |
| Returned To Mfg | 2013-11-22 |
| Catalog Number | UNK_INS |
| 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 | 940000000 | 2013-12-17 |