MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-18 for STERNUM BLADE 0277087100 manufactured by Stryker Instruments-kalamazoo.
[5015444]
It was reported that during a procedure the saw blade broke during the cut. When the blade break was noticed an x-ray was taken and the other part of the blade was found in the patient. It was further reported that this resulted in a surgical delay of 15-20 minutes. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[12557176]
The device was not returned for evaluation. The quality investigation is complete. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[21488964]
It was reported that during a procedure the saw blade broke during the cut. When the blade break was noticed, an x-ray was taken and the other part of the blade was found in the patient. It was further reported that this resulted in a surgical delay of 15-20 minutes. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[21737204]
Device return has been requested. A follow up report will be filed once the quality investigation is complete. Device not yet returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-02573 |
| MDR Report Key | 3943781 |
| Report Source | 06 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-24 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-07-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DERVILLIA MURPHY |
| 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 | STERNUM BLADE |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2014-07-18 |
| Catalog Number | 0277087100 |
| 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 | 1. Other | 2014-07-18 |