MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-08-03 for ANGEL BMC KIT ABS-10062 manufactured by Arthrex, Inc..
[51067647]
Patient demographics (date of birth, weight) 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. The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. Device history record review revealed nothing relevant to this event. This is the first complaint of this type for this part/lot combination. The undetermined cause 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 be discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[51067648]
It was reported that two arthrex angel bone marrow processing kit were being used for a bone marrow aspirate concentrate, proximal tibia procedure. For the first attempt to retrieve bmi from the patient, the jamshidi needle trocar and stylet fused together upon insertion (lot number 526658998). The surgeon was able to retrieve the stylet from the proximal tibia using pliers. A second arthrex angel bone marrow processing kit was opened (lot number 61186428) and the jamshidi needle broke off in the patient's tibia upon removal. The surgeon was able to fully retrieve the broken piece from the patient by creating a larger incision (surgical intervention) to fully retrieve the broken needle tip. The patient received stitches to close up the incision. The bma was successfully collected and spun to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2016-00320 |
| MDR Report Key | 5843872 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-13 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2016-07-13 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-08-03 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2016-08-03 |
| 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 | 2016-08-03 |