MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2013-08-19 for ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING) 307.032 76038-01M manufactured by Knee Creations, Llc.
[3774742]
On (b)(6) 2013, the surgeon performed a knee scope on a (b)(6) year old pt's left knee. The surgeon proceeded to x-ray the knee in order to place the accuport cannula into the medial femoral condyle. Upon placing the cannula he initially went in too far and he tried to back it out using the pin driver. The pin driver was unable to grasp the pin to reverse the pin to back it out. He then tried to spin the pin and cannula manually. He moved the knee back into extended and tried to back it out with the pin driver again. The cannula, slightly proximal to the tip, had broken off and was still in the femur. The surgeon decided that going after the broken piece would do more harm to the bone than good.
Patient Sequence No: 1, Text Type: D, B5
[11120755]
The cannula in question was retrieved and reviewed under close examination. There were no clear visible defects of manufacturing; no clear defects or evidence that would point to the exact nature of the failure. The product failure occurred in the proximal area of the threads in the outer cannula. There were visible scores and marks on the driving stylus pin of the device. It would appear the surgical drill/driver did not adequately grip into the device but left focal scores or marks in some areas. Upon further investigation, the rep present during surgery provided some further details: the pt did weight lifting and most likely had comparably denser hard bone. The surgical drill/driver used in the case was an old driver where the connection loosely fit onto the pin and the drill relied on and pressure to hold onto the pin. The surgery was done freehand without the instrument guide.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008812173-2013-00002 |
| MDR Report Key | 3411550 |
| Report Source | 07,08 |
| Date Received | 2013-08-19 |
| Date of Report | 2013-07-19 |
| Date Mfgr Received | 2013-04-22 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-11-14 |
| 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 | DAVID NICHOLS |
| Manufacturer Street | 900 AIRPORT RD, STE 3B |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 4848878891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING) |
| Generic Name | NONE |
| Product Code | FGY |
| Date Received | 2013-08-19 |
| Returned To Mfg | 2013-08-01 |
| Model Number | 307.032 |
| Catalog Number | 76038-01M |
| Lot Number | 26894 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KNEE CREATIONS, LLC |
| Manufacturer Address | 900 AIRPORT RD STE 3B WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-19 |