MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07,company represent report with the FDA on 2015-07-31 for STABILIT COMPLETE FIRST FRACTURE KIT 3353 manufactured by Dfine Inc..
[6321185]
Per received report: stabilit introducer got stuck in the bone after drilling down the first hand drill. The handle of the introducer made a clicking sound and rotated but the cannula did not rotate. The introducer was removed by hand. In addition, the activation element (ae) would not work. A new ae cable and hand switch were tried before replacing it. The introducer was removed and an on-control drill was used to access the pedical and drill into the vertebral body. A new stabilit introducer was placed and a new ae was used to successfully complete the procedure. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[14236720]
The product has not been received within our facility for evaluation. Upon receipt, final evaluation will be conducted and a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[29983717]
The customer reported issue of the stabilit introducer "getting stuck in the bone after drilling" was confirmed. The slight bend at the distal portion of the stylet confirmed that the unit encountered a dense bone. This is consistent with the damage caused when the unit encountered a hard bone. Although there was no apparent damage noted on the introducer and was safely withdrawn, the use of an on-control drill (manufactured by another company) to access the pedical and drilled into the vertebral body was an indication that the bone may have been sclerotic. This may have been the probable cause of the introducer to get stuck and prevented the cannula from rotating as stated in the report. Per ifu 1523, warning #5: "do not use this product in dense bone; device damage resulting in patient injury may occur. Breakage of the device may require intervention or retrieval". The activation element was not returned for evaluation and therefore, a physical investigation could not be performed to determine the cause of the issue. Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined. All units are 100% visually inspected and tested for its functionality during the manufacturing process. Additionally, a sampling of units is destructively tested to verify the stabilit introducer's integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006396387-2015-00009 |
| MDR Report Key | 4964034 |
| Report Source | 04,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2015-01-07 |
| Date Added to Maude | 2015-08-04 |
| 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 | DAN BALBIERZ |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 951340000 |
| Manufacturer Country | US |
| Manufacturer Postal | 951340000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STABILIT COMPLETE FIRST FRACTURE KIT |
| Product Code | GFI |
| Date Received | 2015-07-31 |
| Returned To Mfg | 2015-08-17 |
| Model Number | NA |
| Catalog Number | 3353 |
| Lot Number | 150601 |
| ID Number | NA |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFINE INC. |
| Manufacturer Address | 3047 ORCHARD PARKWAY SAN JOSE CA 951340000 US 951340000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |