MAUDE Adverse Event Report: ARTHREX, INC. GRASPER, MINI, 2.75 MM 15 DEGREE UP CURVE WITH NON-RATCHETING HANDLE; ACCESSORIES ARTHROSCOPIC

Catalog Number	AR-116180
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
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.Device disposition is unknown but has been requested.If available for evaluation return will be requested.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.Lot number was not provided.Device history record review cannot be performed.Complainant's event typically caused by using excessive force while manipulating tissue, or applying excessive leveraging forces.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 via medwatch (b)(4) that during a non-union of bone after orif (open reduction internal fixation) of ankle a screw or pin from the 2.75 mm 15° curved mini grasper was missing.During the procedure the surgeon was attempting to open the grasper in the patient's ankle joint, but the jaws of the instrument would not open.The instrument was tagged and sent to spd (sterile processing department).After spd cleaned and inspected the instrument, it was found that either a set pin or tiny screw was missing from the jaws of the instrument.The patient had an x-ray performed at the next visit and no metal or retained foreign object was noted.Unclear what happened with the screw.

• Brand Name: GRASPER, MINI, 2.75 MM 15 DEGREE UP CURVE WITH NON-RATCHETING HANDLE
• Common Device Name: ACCESSORIES ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6656256
• Report Number: 1220246-2017-00219
• Device Sequence Number: 1967825
• Product Code: NBH
• UDI-Device Identifier: 00888867003842
• UDI-Public: 00888867003842
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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-116180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/21/2017
• 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: 46 YR