MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-09 for FAN BLADE, OFFSET (19.0 X 0.38 X 41.5MM) 5400134415 manufactured by Stryker Instruments-kalamazoo.
[174374111]
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
[174374112]
It was reported that during a surgical procedure, it was noted that the blade exited the handpiece. 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
[188149155]
This initial mdr was initially filed in error. The event reported in this case was that the blade would not lock into the handpiece. Based on a review of previous events of fitting issues, such events have not caused or contributed to an adverse event or serious injury in patients or users and for future events to occur is unlikely to cause or contribute to a serious injury event. In this event, the blade could not be used and the fitting issue was detected prior to use. No reported adverse consequences to user or patient was reported. As a result this supplemental mdr will note that the initial was filed in error and such an event is not reportable. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[188149156]
It was reported that during a surgical procedure, it was noted that the blade exited the handpiece. 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 | 0001811755-2020-00036 |
| MDR Report Key | 9570260 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-09-29 |
| Date Added to Maude | 2020-01-09 |
| 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 | FAN BLADE, OFFSET (19.0 X 0.38 X 41.5MM) |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL |
| Product Code | GFA |
| Date Received | 2020-01-09 |
| Model Number | 5400134415 |
| Catalog Number | 5400134415 |
| Lot Number | 19272027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-09 |