MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for DUAL CUT SAGITTAL BLADE (18X1.27X100MM) 4118127100 manufactured by Stryker Instruments-kalamazoo.
[177977085]
A follow up report will be filed once the quality investigation is complete. Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[177977086]
It was reported that a blade broke during a total knee arthroplasty procedure. It was further reported that the procedure was completed successfully using a spare blade. It was also reported that there were no delays and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188148960]
The reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation. Without the blade, the root cause cannot be determined. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[188148961]
It was reported that a blade broke during a total knee arthroplasty(tka) procedure. It was further reported that the procedure was completed successfully using a spare blade. It was also reported that there were no delays and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00413 |
| MDR Report Key | 9676534 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-02-06 |
| 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 | DUAL CUT SAGITTAL BLADE (18X1.27X100MM) |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL |
| Product Code | GFA |
| Date Received | 2020-02-06 |
| Model Number | 4118127100 |
| Catalog Number | 4118127100 |
| Lot Number | UNKNOWN |
| 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 | 2020-02-06 |