MAUDE Adverse Event Report: ARTHREX, INC. ANGEL BMC KIT; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Catalog Number	ABS-10062
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ANGEL BMC KIT
• Common Device Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5843872
• Report Number: 1220246-2016-00320
• Device Sequence Number: 1077311
• Product Code: ORG
• UDI-Device Identifier: 00888867083998
• UDI-Public: 00888867083998
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: ABS-10062
• Device Lot Number: 611864248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2016
• Initial Report FDA Received Date: 08/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) ARTHREX ANGEL BMC KIT LOT 526658998
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR