MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM; PLATE, FIXATION, BONE

Catalog Number	AR-14005
Health Effect - Clinical Code	Fracture, Arm (2351)
Date of Event	05/16/2016
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.The device was requested/is expected for evaluation but has not yet been received.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.Additional information has been requested but not made available.Lot number was not provided so device history record review cannot be performed.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.
Event or Problem Description
It was reported that the plate was inserted for a humeral fracture and then post-op the bushing pulled out which caused the screw to pull out of the bone.As a result, a revision surgery had to be performed.Revision surgery was done on (b)(6) 2016 with another manufacturer's plate.

• Brand Name: HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6184917
• Report Number: 1220246-2016-00585
• Device Sequence Number: 11013975
• Product Code: HRS
• UDI-Device Identifier: 00888867016149
• UDI-Public: 00888867016149
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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 Catalogue Number: AR-14005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/19/2016
• 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