MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-08 for ANGEL BMC KIT ABS-10062 manufactured by Arthrex, Inc..
[59353177]
Patient demographics (age at time of event, date of birth) were requested but not provided. No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. No device malfunction identified. At this time, it cannot be determined if the device may have caused or contributed to the patient's experience. An evaluation of the device cannot be performed as the device was not returned to arthrex. Device history record review revealed nothing relevant to this event. Additional information has been requested but not made available. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. This is the first complaint of this type for this part/lot combination. The potential cause(s) of this event will be communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted. Device requested but not yet received.
Patient Sequence No: 1, Text Type: N, H10
[59353178]
It was reported that during a bmc and oa/hto procedure, the operating surgeon attempted to use the trocar from the kit in the osteotomy that was made for the hto but the draw was unsuccessful due to the open system created from the osteotomy. Next the operating surgeon malleted the trocar into the tibial crest about 6 inches distal to the osteotomy and attempted a bmc draw from that site, which was unsuccessful. The surgeon and the sales rep discussed the incident and after discussing with a fellow surgeon they determined that they would try to draw via the notch in the distal femur. The trocar was placed in position and was hit with the mallet and it entered the im cannula. The trocar was met with some resistance and the surgeon stopped immediately. Fluoro was utilized to confirm positioning. The surgeon attempted another draw using the vacuum syringes in the kits. This attempt was unsuccessful and surgeon pulled the trocar out of the femur. When trocar was removed the fellow surgeon realized that the trocar tip was broken. The tip was lodged in the distal femur of the patient. Flouro was used to try and recover the tip but was unsuccessful. Per the sales rep, the operating surgeon determined the broken tip was not protruding into the joint and would not be a problem for the patient leaving it in the distal femur. The patient was informed and the piece of the trocar remained in his femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2016-00484 |
| MDR Report Key | 6085144 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-19 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2016-11-08 |
| 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 | VIK BAJNATH, SR MDR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL BMC KIT |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2016-11-08 |
| Catalog Number | ABS-10062 |
| Lot Number | 621566404 |
| Device Expiration Date | 2018-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-08 |