MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-10-18 for ANGEL BMC KIT ABS-10062- manufactured by Arthrex, Inc..
[57788460]
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 will 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 second 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 reported to discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[57788461]
It was reported that the arthrex angel bmc kit was being used in a bma harvest of the proximal tibia. Advancing the needle with a mallet through the tibia was reported to be difficult. It was also difficult to take the trocar out after advancing the needle, although it was easy to pull back the bma. When finally attempting to pull out the needle, the distal inch of the needle without trocar broke-off and was left in the proximal tibia. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2016-00425 |
| MDR Report Key | 6037746 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-09-23 |
| Date Mfgr Received | 2016-09-23 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-10-18 |
| 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 | 2016-10-18 |
| Catalog Number | ABS-10062- |
| Lot Number | 611864248 |
| Device Expiration Date | 2018-03-01 |
| 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 | 2016-10-18 |