MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-07 for 4.2MM RADIOLUCENT DRILL BIT 4200355042 manufactured by Stryker Instruments-kalamazoo.
[126430768]
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
[126430769]
It was reported that during a osteosynthesis for femoral condylar fracture surgery; the drill bit tip broke. It was further reported that there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[131836283]
Investigation results indicate that contact metal while in use, caused damage to the cutting surface and resulted in a break at the proximal end of the shaft. The associated ifu contains the following caution "caution: excessive pressure can damage either the drill bit or driver. " the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[131836284]
It was reported that during a osteosynthesis for femoral condylar fracture surgery; the drill bit tip broke. It was further reported that there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02384 |
| MDR Report Key | 8047654 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2018-11-07 |
| 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 | MRS. 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 | 4.2MM RADIOLUCENT DRILL BIT |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-11-07 |
| Returned To Mfg | 2018-11-13 |
| Catalog Number | 4200355042 |
| Lot Number | 18135017 |
| 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 | 2018-11-07 |