MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-09 for 4.2MM RADIOLUCENT DRILL BIT 4200355042 manufactured by Stryker Instruments-kalamazoo.
[182589426]
A follow up report will be filed once the quality investigation is complete. Device discarded by customer.
Patient Sequence No: 1, Text Type: N, H10
[182589427]
It was reported that during a surgical procedure, the drill bit broke. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[188145429]
The reported event, for drill bit breakage, was not confirmed as the device was not returned for evaluation. The opinion of the surgeon in this case was that an incorrect angle while drilling caused the drill to break. The instructions for use (ifu) for drive listed for use with this drill contains the following warning "caution: excessive pressure can damage either the drill bit or driver. " without the device, the root cause cannot be determined. Device discarded by customer.
Patient Sequence No: 1, Text Type: N, H10
[188145430]
It was reported that during a surgical procedure, the drill bit broke. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00634 |
| MDR Report Key | 9806612 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-09 |
| 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 Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| 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 | 2020-03-09 |
| Model Number | 4200355042 |
| Catalog Number | 4200355042 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-09 |