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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 6037746
• Report Number: 1220246-2016-00425
• Device Sequence Number: 390809
• Product Code: ORG
• UDI-Device Identifier: 00888867083998
• UDI-Public: 00888867083998
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2016

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: 09/23/2016
• Initial Report FDA Received Date: 10/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR