MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[183513539]
A follow up report will be filed once the quality investigation is complete. Device received but awaiting evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[183513540]
It was reported that during testing, the bur broke. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188145433]
The reported product router fragment involved with this event was returned for evaluation and the reported failure of router breakage was confirmed. As the device could not be identified and that only a partial piece of a router was returned further evaluation of this partial piece of router was not possible. As a result a cause for the bur breakage could not be determined in this case.
Patient Sequence No: 1, Text Type: N, H10
[188145434]
It was reported that during testing, the bur broke. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00695 |
| MDR Report Key | 9834942 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| 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 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES |
| Product Code | HBE |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-06 |
| Catalog Number | UNK_ICO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-16 |