MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-11 for 1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316 manufactured by Stryker Instruments-kalamazoo.
[85639470]
Awaiting device evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[85639471]
It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no adverse consequences as a result of this event. It was further reported that there was a minor delay to get another bur and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[115088532]
Investigation results indicate that the fractured part potentially failed due to overload conditions. A review of the label, #2296-101-760 revision c, indicated that the label displays an icon which equates to "do not use excessive force" using this device.
Patient Sequence No: 1, Text Type: N, H10
[115088533]
It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no adverse consequences as a result of this event. It was further reported that there was a minor delay to get another bur and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01808 |
| MDR Report Key | 6855110 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-11 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2017-12-07 |
| Device Manufacturer Date | 2017-04-28 |
| Date Added to Maude | 2017-09-11 |
| 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 | 1.6MM CROSS-CUT FISSURE CARBIDE BUR |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-08-24 |
| Catalog Number | 2296101316 |
| Lot Number | 17118017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-09-11 |