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 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM) 2108185000 manufactured by Stryker Instruments-kalamazoo.
[174344892]
A follow up report will be filed once the quality investigation is complete. Awaiting device return
Patient Sequence No: 1, Text Type: N, H10
[174344893]
It was reported that there was a potential sterility breach on the packaging of the device, a small hole was found in the pack during a hip procedure. It was also reported that there were no adverse consequences and no delays as a result of this event. It was further reported that the procedure was completed successfully using a back-up device.
Patient Sequence No: 1, Text Type: D, B5
[183823844]
The quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[183823845]
It was reported that there was a potential sterility breach on the packaging of the device, a small hole was found in the pack during a hip procedure. It was also reported that there were no adverse consequences and no delays as a result of this event. It was further reported that the procedure was completed successfully using a back-up device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00032 |
| MDR Report Key | 9570153 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2017-07-05 |
| 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 | 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM) |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL |
| Product Code | GFA |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2020-01-27 |
| Model Number | 2108185000 |
| Catalog Number | 2108185000 |
| Lot Number | 17186017 |
| 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 | 2020-01-09 |