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

Model Number	DRV,3.5MM HEX,CANN (MINI HUDSON)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a case, the tip of the hex driver, ar-8967d, broke while the surgeon was inserting the screw.All fragments were retrieved and the case was completed with no adverse effect to the patient.Additional information provided 12/11/19: procedure being performed was an ankle fusion.Each piece of the driver was removed with adson forceps, a needle driver and also a grasper to get the individual pieces out while utilizing fluoroscopy.The incision was extended 1mm.The case was completed by using the additional 3.5mm hex driver from the 4.5/6.7 tray.The fragments will not be returned with the rest of the driver, the account had concerns washing the small fragments.
Additional Manufacturer Narrative
Complaint confirmed, the hex feature broke off from the device.Likely causes of the event include hitting the device with another object, continually applying torque when the implant is not advancing and/or fully seated.

• Brand Name: DRV,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: 9519516
• Report Number: 1220246-2019-01536
• Device Sequence Number: 3012575
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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 Model Number: DRV,3.5MM HEX,CANN (MINI HUDSON)
• Device Catalogue Number: AR-8967D
• Device Lot Number: 011706
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other