MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX DRIVER SOLID, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1.5MM HEX DRIVER SOLID, CMP FT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
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 an (b)(6) 2020 hammertoe procedure was performed using arthrex ar-8725-xxh compression ft screws.Upon insertion of the headless screws, two of the cannulated 1.5mm hex drivers (ar-8737-37) and one 1.5mm solid driver (ar-8737-45) broke.Standard technique was used to insert the headless compression screws.As the near end of the headless crew was roughly 3 mm from crossing the dip joint, the portion of the cannulated driver engaged with the headless crew broke.The surgeon was attempting to only fuse the pip joint of the 2nd toe.He was able to remove the broken cannulated driver portion from the head of the screw and re-engage a second cannulated driver.The second driver again broke in the same fashion as the first, except this time the surgeon was attempting to back the screw out.A third driver, a solid 1.5 hex, was then used which also subsequently broke.The surgeon then attempted to mallet the screw across the dip joint to no avail.The screw was left crossing both the pip and dip joints and thus altering the end result of the case.Pictures have been provided to arthrex and attached to the file.Additional information obtained 8/19/2020: there were no driver fragments left in the patient.No drill guide was used.The 2.0mm cannulated drill was used over the top of a 0.86 guidewire.The drivers were used by hand.The drivers were discarded at time of procedure and are unavailable to return for evaluation.

• Brand Name: 1.5MM HEX DRIVER SOLID, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10482226
• Report Number: 1220246-2020-02112
• Device Sequence Number: 16448644
• Product Code: LXH
• UDI-Device Identifier: 00888867197787
• UDI-Public: 00888867197787
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 09/02/2020

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: 1.5MM HEX DRIVER SOLID, CMP FT
• Device Catalogue Number: AR-8737-45
• Device Lot Number: 011843
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other