MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-15 for 4.2MM RADIOLUCENT DRILL BIT 4200355042 manufactured by Stryker Instruments-kalamazoo.
[127352392]
The device is available for return. A follow up report will be filed once the quality investigation is complete. Awaiting device return.
Patient Sequence No: 1, Text Type: N, H10
[127352393]
It was reported that during a t2f retroope procedure, the radiolucent drill bit broke during dorsal cortical bone drilling. It was also reported that additional cuts were required to remove the broken piece with a radio pliers. It was further reported that there were no adverse consequences and no delays as a result of this event. It was also reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[133266895]
Investigation results indicate that misalignment between the drill and the nail during use resulted in contact with metal which caused the drill to break at the tip. The associated devices instructions for use (ifu) provides a note on how to realign the drill bit if required during cutting. The ifu states that the device and associated handpieces are "used to drill or ream through bone".
Patient Sequence No: 1, Text Type: N, H10
[133266896]
It was reported that during a t2f retroope procedure, the radiolucent drill bit broke during dorsal cortical bone drilling. It was also reported that additional cuts were required to remove the broken piece with a radio pliers. It was further reported that there were no adverse consequences and no delays as a result of this event. It was also reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02480 |
| MDR Report Key | 8073447 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-15 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-10-21 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-05-28 |
| Date Added to Maude | 2018-11-15 |
| 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 | 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 | 2018-11-15 |
| Returned To Mfg | 2018-11-26 |
| Catalog Number | 4200355042 |
| Lot Number | 18149017 |
| 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 | 1. Other | 2018-11-15 |