MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T8 HEXALOBE SELF RETAINING; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DRIVER, T8 HEXALOBE SELF RETAINING
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/02/2019
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 requested/is expected but has 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
On (b)(6) 2019 it was initially reported that on that day an ar-8916-27 driver was being used during a procedure and the distal tip stripped.The driver was from set ar-8950s (serial number (b)(4)).Additional information provided 2/5/2019: the procedure being performed was a tri-malleolar on the posterior ankle.The distal tip of the driver stripped and broke-off in the hex end of the screw.The tip broke-off and the tip fragment is flush with the face of the screw in the screw head.The screw with fragment was left in the patient.A back-up t8 driver was used to complete the procedure.
Additional Manufacturer Narrative
Complaint confirmed.The drive feature was found to be twisted and the extremity to have broken off from the device.The device was found to meet dimensional and material specification.The most likely cause(s) of this type of event include continually applying torque when the implant is not properly aligned, leveraging, or torquing while leveraging the device.

• Brand Name: DRIVER, T8 HEXALOBE SELF RETAINING
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8357221
• Report Number: 1220246-2019-00915
• Device Sequence Number: 183540
• Product Code: MDM
• UDI-Device Identifier: 00888867177628
• UDI-Public: 00888867177628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/19/2019

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: DRIVER, T8 HEXALOBE SELF RETAINING
• Device Catalogue Number: AR-8916-27
• Device Lot Number: 1391618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other