MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-05 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[101511260]
A follow up report will be filed once the quality investigation is complete. Awaiting device return to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[101511261]
It was reported that a blade was broken in the associated handpiece device. It was also reported that there was no patient involvement, no delay, no medical intervention, and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-00474 |
| MDR Report Key | 7312565 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-05 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-03-05 |
| 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 | MR. 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 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2018-03-05 |
| Catalog Number | UNK_ICO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2147483647 | 2018-03-05 |