MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-25 for 4.2MM RADIOLUCENT DRILL BIT 4200355042 manufactured by Stryker Instruments-kalamazoo.
[186735248]
A follow up report will be filed once the quality investigation is complete. Awaiting return of device to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[186735249]
It was reported that during a t2 tibia surgery, two radiolucent drill bits broke. It was further reported that one of the drill bits was reused. It was also reported that there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully. This record addresses one of the drill bit breaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00786 |
| MDR Report Key | 9876515 |
| Report Source | OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 4200355042 |
| Catalog Number | 4200355042 |
| Lot Number | 19288017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-25 |