MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-06-02 for EXPRESS CURETTE A13A manufactured by Medtronic Spine Llc..
[2003962]
It was reported that: during a kyphoplasty procedure at level l1, the express curette could not be pulled out of the working cannula. It appeared the distal end of the curette had broke during the procedure. The curette had to be pulled out with the working cannula at the same time. The procedure was completed successfully and the patient status is good. There was no patient injury. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
[9021832]
Evaluation summary: received 1 t-tip curette for evaluation. The curette remains in the working cannula and cannot be removed. The cannula is tight on the curette shaft. It is unknown if the curette shaft is bent. The head of the curette splayed the pivot pin is disconnected from the weld joints on both sides of the head a fracture of the head on the right side is observed torque reset mechanism is still in working condition lever and locking switch are still working; however, the tip does not articulate conclusion: the reported complaint of curette retraction difficulty was confirmed with the product return. The curette could not be removed from the working cannula and the curette head was damaged. Probable root cause: it is likely that the head splayed due to torsional forces applied by the user. This would put pressure on the pivot pin causing it to disconnect from the weld joints. Method; followed up with company representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2011-00070 |
| MDR Report Key | 2112012 |
| Report Source | 05,07 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-05-10 |
| Date of Event | 2011-05-10 |
| Date Mfgr Received | 2011-05-10 |
| Device Manufacturer Date | 2010-12-14 |
| Date Added to Maude | 2011-10-05 |
| 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 | MICHAEL ARMSTRONG |
| Manufacturer Street | MEDTRONIC SPINE LLC. 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Manufacturer G1 | KYPHON |
| Manufacturer Street | MEDTRONIC SPINE LLC. 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRESS CURETTE |
| Product Code | HTF |
| Date Received | 2011-06-02 |
| Returned To Mfg | 2011-05-25 |
| Catalog Number | A13A |
| Lot Number | 0005588523 |
| Device Expiration Date | 2012-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC. |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-02 |