MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-15 for 1.2MM TAPER SIDE CUTTING CARBIDE BUR 1607002105 manufactured by Stryker Instruments-kalamazoo.
[97408936]
A follow up report will be filed once the quality investigation is complete. Awaiting device return to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[97408937]
It was reported that during a surgical procedure, it was noted that when the nurse opened the pack, the tip of the bur was broken. It was also reported that there were no delays and no adverse consequences as a result of this event. It was further reported the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-00051 |
| MDR Report Key | 7189263 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-15 |
| Date of Report | 2018-03-12 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-01-15 |
| 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 | 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 | 1.2MM TAPER SIDE CUTTING CARBIDE BUR |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-02-15 |
| Catalog Number | 1607002105 |
| 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 | 2018-01-15 |