MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-24 for ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING) 307.032 76038-01M manufactured by Knee Creations Llc.
[3170234]
During a bone void filling procedure of a femoral condyle of the right knee the surgeon used accuport side targeted (self-drilling) cannula, part (b)(4). He performed the procedure by free hand- meaning he chose not to use the navigation targeting guide instruments that were provided with the cannula for the procedure. During initial targeting and insertion of the cannula, the surgeon believed he did not adequately target the bone void so he removed the cannula partially from the initial site and directed the cannula to a new location in the bone. After the introduction of bone substitute material to the site, the surgeon left the cannula inside the bone and stated he was unable to reinsert the inner cannula stylus. The surgeon then proceeded with an arthroscopy and acl reconstruction on the same knee with the cannula still inside the bone. The knee was flexed, extended, and manipulated during this part of the procedure. Following the second part of the procedure, the surgeon proceeded to remove the cannula. As he removed the cannula, approximately 10 to 15mm of the tip remained inside the femoral condyle.
Patient Sequence No: 1, Text Type: D, B5
[10509750]
During testing in house, the product failure was able to be replicated. From further analysis and investigation, it was determined that the product failure was a result of failure to follow manufacturer instructions by the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008812173-2013-00001 |
| MDR Report Key | 2975230 |
| Report Source | 07 |
| Date Received | 2013-01-24 |
| Date of Report | 2013-01-03 |
| Date Mfgr Received | 2012-12-31 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-04-15 |
| 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 | 6103501140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING) |
| Generic Name | NONE |
| Product Code | FGY |
| Date Received | 2013-01-24 |
| Returned To Mfg | 2013-01-07 |
| Model Number | 307.032 |
| Catalog Number | 76038-01M |
| Lot Number | 25878 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-01-24 |