MAUDE Adverse Event Report: EXACTECH, INC. NOV 6.5MM HEX DRIVER ARTICULATING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	NOV 6.5MM HEX DRIVER ARTICULATING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the tip of 6.5 hex drive broke off at the end of the screwdriver head.The surgical site was checked, and no instrumentation was left in the surgical field, it was confirmed clean by surgeons.This event caused no delay and the procedure proceeded with no issues.Patient is currently in stable condition.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the fractured universal hex driver reported was likely the result of applying torque greater than the yield strength of the material, possibly secondary to contributions from either hard bone or insufficient drilling depth during bone preparation, that resulted in the shearing off of the driver hex tip.The most probable root cause associated with the reported event of "broken / non-functional" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: NOV 6.5MM HEX DRIVER ARTICULATING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13206145
• Report Number: 1038671-2022-00024
• Device Sequence Number: 19254028
• Product Code: LXH
• UDI-Device Identifier: 10885862038661
• UDI-Public: 10885862038661
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NOV 6.5MM HEX DRIVER ARTICULATING
• Device Catalogue Number: 181-65-02
• Device Lot Number: 67726003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown