MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-07 for * 2296-100-316 KM94702LN manufactured by Howmedica Osteonics Corp Aka Stryker Orthopaedics.
[16780769]
Drill bit was sheared off at the tip during testing of handpiece. It did not reach patient. New drill bit opened and replaced for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3436513 |
| MDR Report Key | 3436513 |
| Date Received | 2013-10-07 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-09-24 |
| Report Date | 2013-10-07 |
| Date Reported to FDA | 2013-10-07 |
| Date Reported to Mfgr | 2013-10-30 |
| Date Added to Maude | 2013-10-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BURR |
| Product Code | HTT |
| Date Received | 2013-10-07 |
| Model Number | 2296-100-316 |
| Catalog Number | KM94702LN |
| Lot Number | KM94702LN |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS |
| Manufacturer Address | 325 CORPORATE DR. MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-07 |