MAUDE Adverse Event Report: ARTHREX INC. DRIVER,3.5MM HEX,CANN (MINI HUDSON); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-8967D
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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 device was requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.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.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a distal femur fx-rle procedure, upon meeting resistance from two 6.3 herbert screws implanted first, the 3.5 hex driver broke upon initial insertion of a 6.7 mm fully threaded cannulated screw, ar-8967-60ft.The tip broke into several fragments, which were all retrieved by extending the incision site.The 6.7 fully threaded screw was removed with backup 3.5 hex driver.Patient is a male, (b)(6).
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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 history record review revealed nothing relevant to this event.Complaint confirmed.Material analysis confirmed correct material type.The evaluation confirmed a jagged break to the tip of the driver, which had broken into three pieces.Complainant's event typically caused when the joint is flexed during insertion of the implant with the driver engaged or prying/leveraging of the driver.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a distal femur fx-rle procedure, upon meeting resistance from two 6.3 herbert screws implanted first, the 3.5 hex driver broke upon initial insertion of a 6.7mm fully threaded cannulated screw, ar-8967-60ft.The tip broke into several fragments, which were all retrieved by extending the incision site.The 6.7 fully threaded screw was removed with backup 3.5 hex driver.Patient is a male, (b)(6).

• Brand Name: DRIVER,3.5MM HEX,CANN (MINI HUDSON)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7600194
• Report Number: 1220246-2018-00223
• Device Sequence Number: 19230000
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: 00888867056718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 08/02/2018

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-8967D
• Device Lot Number: 21509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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